Weekly 510(k) Roundup September 23, 2024

510(k)s at a Glance for week of September 23, 2024:

• Anesthesiology: 2
• Cardiovascular: 4
• Clinical Chemistry: 1
• Dental: 7
• Ear, Nose, Throat: 1
• Gastroenterology, Urology: 2
• General Hospital: 7
• General, Plastic Surgery: 6
• Neurology: 4
• Obstetrics/Gynecology: 1
• Orthopedic: 11
• Physical Medicine: 4
• Radiology: 7

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510(k) Detail

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

Anesthesiology

Average 510(k) decision time: 240 days

• K241465 Parker Hannifin Corporation - Midas Flowmeter; Eavs (119 days, -121 days)
• ??K240293 Techbopulm, Ltd. - Sts (229 days, -11 days)

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Cardiovascular

Average 510(k) decision time: 152 days

• ??K232670 Mezoo Co., Ltd. - Hicardi+ H100 (385 days, +233 days)
• K240901 Sparrow Acoustics Inc. - Stethophone (170 days, +18 days)
• K241784 Teleflex Medical - Arrow? Nitinol Wire (90 days, -62 days)
• K241230 Togo Medikit Co., Ltd. - Super Sheath Introducer Sheath S-3N5/1005 S-3N7/1006 S-3W5/1007 S-3W7/1008 (138 days, -14 days)

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Clinical Chemistry

Average 510(k) decision time: 227 days

• ??K241335 Senseonics, Incorporated - Eversense 365 Continuous Glucose Monitoring (Cgm) System (126 days, -101 days)

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Clinical Toxicology

Average 510(k) decision time: 155 days

• None

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Dental

Average 510(k) decision time: 180 days

• K241880 Nakanishi Inc. - Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing System (Perio Mate Nozzle Tip) (84 days, -96 days)
• ??K240183 Dentalez, Inc., Stardental Division - Star E900 Handpiece Series (240 days, +60 days)
• K233064 Whitepeaks Dental Solutions Gmbh - Copra Supreme (358 days, +178 days)
• K234142 Megagen Implant Co., Ltd. - Tigen Abutment, Pmma Abutment And Scan Healing Abutment (264 days, +84 days)
• K233721 Kls-Martin L.P. - Kls Martin Drill-Free Mmf Screw (301 days, +121 days)
• K240660 Kulzer, Llc - Signum Composite Flow; Signum Universal Bond; Signum Metal Bond ; Signum Composite; Signum Matrix; Signum Liquid; Signum Cre-Active (193 days, +13 days)
• K234089 Vivos Therapeutics - Dna Appliance (269 days, +89 days)

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Ear, Nose, Throat

Average 510(k) decision time: 169 days

• ??K234096 Medicaltek Co., Ltd. - Monostereo (268 days, +99 days)

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Gastroenterology, Urology

Average 510(k) decision time: 155 days

• ?? Innocare Urologics, Llc - Innocare Specialty Foley Catheter (121 days, -34 days)
• K240274 Steris Corporation - Padlock Clip Eftr Kit (00713229) (230 days, +75 days)

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General Hospital

Average 510(k) decision time: 166 days

• ??K234129 Ecomed Solutions, Llc - Ecomed Disposable Administration Sets (267 days, +101 days)
• K241821 Sol-Millennium Medical Inc. - Luer Lock Syringe With Safety Needle; Luer Lock Syringe With Exchangeable Needle; Luer Lock Syringe With Blunt Fill Needle (88 days, -78 days)
• ??K231893 Lowtem Co., Ltd. - Lowtem Crystal 120 (448 days, +282 days)
• K241123 Km Corp. - Perpak? Sterilization Tyvek Pouch (148 days, -18 days)
• K231383 Terragene Sa - Terragene? Bionova? Self-Contained Biological Indicator (Bt95), Terragene? Bionova? Self-Contained Biological Indicator (Bt96), Terragene? Chemdye? Chemical Process Indicator (Cd42), Terragene? Cintape? Chemical Process Indicator Tape (Ct40) (495 days, +329 days)
• K234132 Medline Industries, Lp - Medline Reusable Sterilization Wrappers (264 days, +98 days)
• K234050 O&M Halyard, Inc. - Halyard? One-Step? Sterilization Wrap, Halyard? Quick Check? Sterilization Wrap, Halyard? Sequential Sterilization Wrap And Halyard? Smart-Fold? Sterilization Wrap (270 days, +104 days)

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General, Plastic Surgery

Average 510(k) decision time: 149 days

• ??K240722 Raya Pharmaceuticals Llc - Derma-R Cream (Derma-R Cream) (186 days, +37 days)
• K241825 Canyon Medical Inc. - Microwave Ablation Antennas (88 days, -61 days)
• ?? M&T S.R.L. - Mtone Evo (Mtone Evo) (200 days, +51 days)
• ??K240689 Telebrands Corporation - Robin'S Egg (188 days, +39 days)
• ??K241771 Medical San Indústria De Equipamentos Médicos Ltda. - Liftendo; Liftendo 2.0 (88 days, -61 days)
• ??K241762 View Point Medical - Onemark (88 days, -61 days)

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Hematology

Average 510(k) decision time: 248 days

• None

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Immunology

Average 510(k) decision time: 198 days

• None

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Microbiology

Average 510(k) decision time: 280 days

• None

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Neurology

Average 510(k) decision time: 162 days

• K242504 Perfuze Ltd. - Millipede 088 Access Catheter; Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set (29 days, -133 days)
• ??K240420 Neurofield Inc. - Neurofield Analysis Suite (220 days, +58 days)
• K233153 Saeshin Precision Co., Ltd. - Traus Ssg10 Surgical System (359 days, +197 days)
• K232938 Saeshin Precision Co., Ltd. - Traus Ssg30 Surgical System (362 days, +200 days)

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Obstetrics/Gynecology

Average 510(k) decision time: 176 days

• K242162 Good Clean Love, Inc. - Coconut Hybrid (57 days, -119 days)

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Ophthalmic

Average 510(k) decision time: 185 days

• None

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Orthopedic

Average 510(k) decision time: 122 days

• K241332 Carlsmed, Inc. - Aprevo? Anterior And Lateral Lumbar Interbody Fusion Device; Aprevo? Anterior Lumbar Interbody Fusion Devices With Interfixation; Aprevo? Transforaminal Lumbar Interbody Fusion Device (133 days, +11 days)
• K242147 Alphatec Spine, Inc. - Calibrate Ltx Interbody System; Calibrate Nanotec Ltx Interbody System (59 days, -63 days)
• K240061 Smith & Nephew, Inc. - Trigen Max Tibial Nail System; Intertan Max Hip Fracture Nail System (255 days, +133 days)
• ??K242650 Zygofix Ltd. - Zlock Lumbar Facet Fixation System (16 days, -106 days)
• K242509 Next Orthosurgical - Hanano Interfuse(R) Modular Interbody (28 days, -94 days)
• K241709 Biomet Microfixation - Pectus Blu Support Bar System (98 days, -24 days)
• ??K241769 Response Ortho Solutions Llc - Response Ortho Metaphyseal Hinge Fixator System (90 days, -32 days)
• ??K241775 Xelite Biomed Ltd. - Xelitemed Vertehighfix High Viscosity Spinal Bone Cement (90 days, -32 days)
• K240250 Nvision Biomedical Technologies, Inc. - 3D Printed Peek Interbody System (231 days, +109 days)
• K241942 Trimed, Inc. - Trimed Bridge Plates (77 days, -45 days)
• K241893 Medos International Sarl - Crossnav Navigation Enabled Instruments And Unas Navigation Arrays (80 days, -42 days)

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Pathology

Average 510(k) decision time: 378 days

• None

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Physical Medicine

Average 510(k) decision time: 178 days

• K240373 Zhangzhou Easepal Medical Science And Technology Co., Ltd. - Air Compression Leg Massager (Mm0520, Mm0521, Mm0522) (223 days, +45 days)
• ??K242186 Ofan Intelligent Technology (Guangzhou) Co. Ltd. - Neo Sculptor (Of-Neo001) (54 days, -124 days)
• ??K240638 Ningbo Youhuan Automation Technology Co., Ltd. - Power Wheelchair (Yh-E7007) (194 days, +16 days)
• ??K241379 Zhejiang Nysin Medical Co., Ltd. - Powered Wheelchair (Nxn20-205, Nxn20-205M) (124 days, -54 days)

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Radiology

Average 510(k) decision time: 148 days

• ??K234108 Energy Resources International Co., Ltd. - Eri Portable X-Ray System (Cvx-Air); Eri Portable X-Ray System (Cvx-Lite); Eri Portable X-Ray System (Cvx-E) (268 days, +120 days)
• ??K240036 Piur Imaging Gmbh - Piur Tus Infinity (259 days, +111 days)
• K242223 Supersonic Imagine - Supersonic Hepavu (53 days, -95 days)
• K242478 Samsung Electronics Co., Ltd. - Gf85 (Models Gf85-3P, Gf85-Sp) (29 days, -119 days)
• ??K242167 Anhui Deepblue Medical Technology Co.,Ltd. - Sterile And Non-Sterile Ultrasonic Coupling Agent (57 days, -91 days)
• ??K234153 Edgelife Technologies Llc - Edgelife Handheld Wireless Ultrasound System (E8200); Edgelife Handheld Wireless Ultrasound System (E8220) (264 days, +116 days)
• K241201 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. - Tex20/Tex20 Pro/Tex20S/Tex20T/Tex20 Exp/Tex20 Elite/Tex10/Tex10 Pro/Tex10S/Tex10T/Tex10 Exp/Tex10 Elite/Te X/Te X Lite/Anesus Tex20 Pro/Eagus Tex20/Eagus Tex20T/Eagus Tex21/Eagus Tex21T/Eros/Te X Plus/Anesus Tex10 Pro/Tex9U/Tex9M/Eagus Tex11/Eagus Tex11T/Eagustex10/Eagus Tex10T/Eagus Tex/Ares Diagnostic Ultrasound System (139 days, -9 days)

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