Weekly 510(k) Roundup November 25, 2024

510(k)s at a Glance for week of November 25, 2024:

Anesthesiology: 4
Cardiovascular: 3
Clinical Chemistry: 3
Clinical Toxicology: 1
Dental: 3
Ear, Nose, Throat: 1
Gastroenterology, Urology: 2
General Hospital: 2
General, Plastic Surgery: 9
Hematology: 1
Microbiology: 1
Neurology: 7
Obstetrics/Gynecology: 2
Orthopedic: 14
Physical Medicine: 7
Radiology: 11

About Marcus Engineering LLC

Marcus Engineering LLC is a leading electronics-focused product development and prototyping organization.

We are experts in:

Medical device design, software, and security.
End to end product development
High-security, high-risk medical devices
Cybersecurity and supporting regulatory compliance

?

510(k) Detail

Companies receiving their first 510(k) are marked with a ?? .

Anesthesiology

Average 510(k) decision time: 222 days

?? K241953 Pajunk Gmbh Medizintechnologie - Sprotte? Standard (Luer/ Nrfit?) Anesthesiology (142 days, -80 days)
K240569 Fink Engineering Pty Ltd - Fesl Fink Chamber; Fedl Fink Chamber; Fetl Fink Chamber (266 days, +44 days)
?? K232520 Shenzhen Smallsignal Technology Co., Ltd. - Fingertip Pulse Oximeter, Models Alpine20, Alpine20A, Alpine20H, Alpine20Ha, Alpine20B, Alpine20Ba, Alpine20Bh, Alpine20Bha, Alpine30, Alpine30A, Alpine30H, Alpine30Ha, Alpine30B, Alpine30Ba, Alpine30Bh, Alpine30Bha, Alpine20L, Alpine20Lb, Alpine20Lh, Alpine20Lbh, Alpine30L, Alpine30Lb, Alpine30Lh, Alpine30Lbh (461 days, +239 days)
K241843 Gostar Co., Ltd - Td-7301 Spirometer (Td-7301) (147 days, -75 days)

?

Cardiovascular

Average 510(k) decision time: 158 days

K242520 Penumbra, Inc. - Element Vascular Access System (89 days, -69 days)
?? K241633 Mindset Medical, Inc. - Informed Vital Core Application (Ivc App) (165 days, +7 days)
K242092 Sorin Group Italia S.R.L. - Micro Arterial Filters (124 days, -34 days)

?

Clinical Chemistry

Average 510(k) decision time: 226 days

K221326 Nova Biomedical Corporation - Nova Allegro Hba1C Assay, Nova Allegro Analyzer (931 days, +705 days)
K221813 Nova Biomedical Corporation - Nova Allegro Uacr Assay, Nova Allegro Analyzer (881 days, +655 days)
K221349 Taidoc Technology Corporation - Xper Technology Premium Pro Blood Glucose Monitoring System (925 days, +699 days)

?

Clinical Toxicology

Average 510(k) decision time: 91 days

?? K243064 Eterbio, Inc. - Eterbio Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); Eterbio Fentanyl/Norfentanyl Home Test (54 days, -37 days)

?

Dental

Average 510(k) decision time: 183 days

K242884 Aidite (Qinhuangdao) Technology Co., Ltd. - Additively Manufactured Denture Resin (60 days, -123 days)
K242913 Jasberry Healthcare Private Limited - Jasmate? Toothpaste (59 days, -124 days)
K242521 Osstem Implant Co., Ltd. - Estar-Ze (89 days, -94 days)

?

Ear, Nose, Throat

Average 510(k) decision time: 158 days

K242028 Dongguanshi Yiyingmei Technology Co., Ltd. - Nasal Aspirator (Bc-021, Bc-022, Bc-023, Bc-024, Bc-025, Bc-026) (131 days, -27 days)

?

Gastroenterology, Urology

Average 510(k) decision time: 159 days

K241169 Gravitas Medical, Inc. - Entarik Ni Feeding Tube System (210 days, +51 days)
K241210 Coloplast Corp - Luja Coude (205 days, +46 days)

?

General Hospital

Average 510(k) decision time: 171 days

K242291 Sol-Millennium Medical Inc. - Sol-M Luer Lock Syringe (Low Dead Space) W/O Needle, Sol-M Slip Tip Syringe (Low Dead Space) W/O Needle, Sol-M Luer Lock Syringe (Low Dead Space) W/Exchangeable Needle, Sol-Care Luer Lock Syringe (Low Dead Space) W/Safety Needle, Sol-M Slip Tip Syringe (Low Dead Space) W/Exchangeable Needle (110 days, -61 days)
K242102 Cerrozone Llc - Cerrozone Mini (124 days, -47 days)

?

General, Plastic Surgery

Average 510(k) decision time: 149 days

K242927 Advamedix, Gmbh - Suction Irrigation Tubing Set (59 days, -90 days)
?? K242553 General Vibronics, Inc. - Mirari? Cold Plasma System ( Gv-M2-01) (86 days, -63 days)
K241157 Ilooda Co,.Ltd. - Secret Max Multi-Platform Rf System (209 days, +60 days)
K242363 Shenzhen Kaiyan Medical Equipment Co., Ltd - Higherdose Red Light Hat (Hg-120K) (103 days, -46 days)
K243164 Indiba S. A. U. - Indiba Compact Devices (51 days, -98 days)
K242293 Rhein Laser Technologies Co., Ltd. - Medical Thulium Fiber Laser Systems (Urofiber 60Q) (109 days, -40 days)
K241814 Intuitive Surgical, Inc. - Da Vinci Sp Instruments (Sp1098) (147 days, -2 days)
?? K241498 Hebei Keylaser Sci-Tech Co., Ltd. - Diode Laser Treatment System (K18) (174 days, +25 days)
K241700 Trice Medical, Inc. - Tenex 2Nd Generation System (158 days, +9 days)

?

Hematology

Average 510(k) decision time: 208 days

?? BK241095 Bimini Health Tech - Platelet And Plasma Separator For Bone Graft Handling: Healeon Float Prp (113 days, -95 days)

?

Immunology

Average 510(k) decision time: 130 days

None

?

Microbiology

Average 510(k) decision time: 258 days

K243405 Cepheid? - Xpert Vana (20 days, -238 days)

?

Neurology

Average 510(k) decision time: 163 days

K242259 Cala Health, Inc. - Cala Kiq (114 days, -49 days)
K242094 Beacon Biosignals, Inc. - Dreem 3S (128 days, -35 days)
?? K240632 Neuvotion Inc. - Neuvotion Neustim Nn-01 (261 days, +98 days)
??K243334 Xf Agencija Limited - Nooro Body & Foot Stimulator (Sm9141, Sm9142) (29 days, -134 days)
??K240746 Q'Apel Medical, Inc. - Neurovascular Access System Family (246 days, +83 days)
??K242930 Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) - Natus Brainwatch System (56 days, -107 days)
??K240871 Enlight Medical Technologies (Shenzhen) Co., Ltd. - Synxess Neurovascular Guidewire (234 days, +71 days)

?

Obstetrics/Gynecology

Average 510(k) decision time: 177 days

K242002 Femasys Inc. - Femvue Mini Saline-Air Device (136 days, -41 days)
K242968 Gimbo Medical Technology Shenzhen Co., Ltd. - Giftlife? Single-Step Medium Plus (57 days, -120 days)

?

Ophthalmic

Average 510(k) decision time: 177 days

None

?

Orthopedic

Average 510(k) decision time: 122 days

?? K233567 Flower Orthopedics Corporation Dba Conventus Flower Ortho - Osteocoil? Nitinol Compression System (Multiple Component Pns) (382 days, +260 days)
K242543 Zimmer, Inc. - Persona The Personalized Knee System (Persona Ti-Nidium Pps Femurs) (88 days, -34 days)
K242871 Depuy Ireland Uc - Attune? Revision Hinge Knee (59 days, -63 days)
?? K242998 Gm Dos Reis Industria E Comercio Ltda - Gmreis Ankle Plating System (56 days, -66 days)
K242799 Lifenet Health - Pliafx Flo (65 days, -57 days)
K242414 Surgentec Llc - Tilink-P Joint Fusion System (99 days, -23 days)
?? K242596 Gm Dos Reis Industria E Comercio Ltda - Versalock Mini And Micro Plating System (83 days, -39 days)
K240716 Smith & Nephew, Inc. - Aetos Shoulder System Stemless Humeral Prosthesis (250 days, +128 days)
K240856 Osartis Gmbh - Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer Molds (237 days, +115 days)
K242517 Pro Surgical, Inc. - Proam Acdf System (89 days, -33 days)
K242516 Mirus, Llc - Europa? Posterior Cervical Fusion System (88 days, -34 days)
K243277 Maxx Orthopedics, Inc. - Freedom? Medial Congruent Liner (34 days, -88 days)
K243323 Riverpoint Medical - Iconix Knotless Anchor (27 days, -95 days)
K243506 Orthocon Inc. - Montage-Xt Settable Bone Putty (6 days, -116 days)

?

Pathology

Average 510(k) decision time: 295 days

None

?

Physical Medicine

Average 510(k) decision time: 166 days

K242722 Sichuan Ast Medical Equipment Co., Ltd - Manual Wheelchair (Masy23) (73 days, -93 days)
K241529 Zhejiang Nysin Medical Co., Ltd. - Powered Wheelchair (Nxn20-209) (176 days, +10 days)
K232965 Shenzhen Ruiyi Business Technology Co., Ltd. - Leg Massager (Models:Rp-Alm070H, Rp-Alm071H) (426 days, +260 days)
K241603 Zhejiang Nysin Medical Co., Ltd. - Powered Wheelchair (Nxn20-208, Nxn20-211) (169 days, +3 days)
K243320 Xiamen Weiyou Intelligent Technology Co.,Ltd. - Air Pressure Therapy System (Vu-Ipc04B) (26 days, -140 days)
K242402 Zhejiang Zhonglei Medical Technology Co.Ltd. - Power Wheelchair (97 days, -69 days)
K242471 Zhejiang Innuovo Rehabilitation Devices Co., Ltd. - Power Wheelchair (W5538) (90 days, -76 days)

?

Radiology

Average 510(k) decision time: 146 days

K242203 Aidoc Medical, Ltd. - Briefcase-Quantification (119 days, -27 days)
K242874 Varian Medical Systems, Inc. - Gating Reflector Block (59 days, -87 days)
K241495 Jazz Imaging - Jazz Classic (177 days, +31 days)
K241319 Konica Minolta, Inc. - Skr 3000 (195 days, +49 days)
K242359 Exo Inc - Strain Ai (Sai001) (103 days, -43 days)
K243045 Braxx Biotech Co. Ltd - “Braxx” Esophageal Brachytherapy Applicator (Model: Bkmi2001, Bkmi2002) (53 days, -93 days)
K242523 Siemens Medical Solutions Usa, Inc. - Acuson Sequoia Diagnostic Ultrasound System; Acuson Sequoia Select Diagnostic Ultrasound System; Acuson Origin Diagnostic Ultrasound System; Acuson Origin Ice Diagnostic Ultrasound System (88 days, -58 days)
?? K242496 Eieling Technology (Shenzhen) Limited - Portable Liver Elastography Ultrasound Diagnostic System (Liverscan C) (89 days, -57 days)
K243316 Polarean, Inc. - Xenoview 3.0T Chest Coil (28 days, -118 days)
K242329 Philips Healthcare (Suzhou) Co., Ltd - Ct Collaboration Live (104 days, -42 days)
K241747 Deephealth, Inc - Saige-Dx (153 days, +7 days)

?