Weekly 510(k) Roundup December 02, 2024

510(k)s at a Glance for week of December 02, 2024:

• Anesthesiology: 2
• Cardiovascular: 6
• Dental: 5
• Gastroenterology, Urology: 4
• General Hospital: 4
• General, Plastic Surgery: 7
• Hematology: 1
• Microbiology: 2
• Neurology: 2
• 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: 220 days

• ?? K241090 Movano Inc. Dba Movano Health - Evie Med Ring (221 days, +1 days)
• K232588 Knox Medical Diagnostics - Aluna 2 (458 days, +238 days)

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Cardiovascular

Average 510(k) decision time: 159 days

• K242225 Surgical Instrument Service And Savings Inc. - Medline Renewal Reprocessed Abbott Inquiry Steerable Diagnostic Catheter (123 days, -36 days)
• K243118 Shenzhen Imdk Medical Technology Co., Ltd. - Arm Blood Pressure Monitor (Model: Bpm-A7Vl) (57 days, -102 days)
• K243193 Circa Scientific, Inc. - Cross Wise? Multi-Use Rf Adapter Cable (57 days, -102 days)
• K240818 Terumo Corporation - R2P Radifocus Glidewire Advantage (246 days, +87 days)
• K242971 Heroic Faith International Ltd. - Accursound Electronic Stethoscope (As101) (60 days, -99 days)
• ?? K241851 Liquet Medical Inc. - Versus? Catheter (Vs110-8B) (151 days, -8 days)

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Clinical Chemistry

Average 510(k) decision time: 234 days

• None

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Clinical Toxicology

Average 510(k) decision time: 89 days

• None

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Dental

Average 510(k) decision time: 183 days

• K233273 Prevest Denpro Limited - C&B Ceramic; C&B Permanent; C&B Interim (425 days, +242 days)
• K242559 Sprintray Inc. - Digital Temp (90 days, -93 days)
• K231859 Dentscare Ltda - Primmaart (522 days, +339 days)
• K242245 Arum Dentistry Co., Ltd. - Customized Abutment (117 days, -66 days)
• K241692 Dentsply Sirona Inc. - Mis Lynx Conical Connection Implant System (166 days, -17 days)

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Ear, Nose, Throat

Average 510(k) decision time: 157 days

• None

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Gastroenterology, Urology

Average 510(k) decision time: 159 days

• ?? K243409 Karl Storz Se & Co. Kg - Karl Storz Pediatric Cysto-Urethro-Fiberscope (11274Bcu1) (26 days, -133 days)
• K241899 Easymed Instruments Co., Ltd. - Pelvic Floor Stimulator (Intrelief Pfe) (152 days, -7 days)
• ?? K240650 Traferox Technologies Inc. - Lungprotect (264 days, +105 days)
• K242049 Coloplast Corp - Surecath Set (137 days, -22 days)

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General Hospital

Average 510(k) decision time: 170 days

• K241353 Bard Access Systems, Inc. - Powerloc? Max Power Injectable Infusion Set; Safestep? Huber Needle Set (198 days, +28 days)
• K243354 Deka Research & Development Corp. - Remunity System (29 days, -141 days)
• ?? K241115 Spectrum Vascular - Sv Spectrum Mrc Central Venous Catheter; Sv Spectrum Mr Central Venous Catheter; Sv Central Venous Catheter (218 days, +48 days)
• K242538 3M Company - 3M? Attest? Super Rapid Readout Biological Indicator 1493; 3M? Attest? Super Rapid Steam Gravity Clear Challenge Pack 1493Pcdg; 3M? Attest? Auto-Reader 490; 3M? Attest? Auto-Reader 490H; 3M? Attest? Mini Auto-Reader 490M (91 days, -79 days)

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General, Plastic Surgery

Average 510(k) decision time: 150 days

• K241835 Cellmyx - Airsculpt Body Contouring System (Airs-1-Sys) (155 days, +5 days)
• ?? K242796 Sharkninja Operating, Llc - Cryoglow (Fw3Xxxx) (72 days, -78 days)
• ?? K242638 Shenzhen Walton Technology Co., Ltd. - Led Light Therapy Machine (G1, G3, G4, G6) (85 days, -65 days)
• K240994 Nextbiomedical Co., Ltd. - Nexpowder (230 days, +80 days)
• K243362 Cyden Limited - Smoothskin Pure Switch (Ssc1) (29 days, -121 days)
• K240897 Viol Co. Ltd - Cellinew (239 days, +89 days)
• K242318 Intuitive Surgical, Inc. - Da Vinci Sp Surgical System (Sp1098) (113 days, -37 days)

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Hematology

Average 510(k) decision time: 246 days

• K241628 Medical Electronic Systems Ltd. - Yo Home Sperm Test (176 days, -70 days)

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Immunology

Average 510(k) decision time: 133 days

• None

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Microbiology

Average 510(k) decision time: 257 days

• K242657 Thermofisher Scientific - The Sensititre 18-24 Hour Mic Or Breakpoint Susceptibility System With Daptomycin In The Dilution Range Of 0.03-64 Ug/Ml (83 days, -174 days)
• K243345 Hologic, Inc. - Aptima Bv Assay; Aptima Cv/Tv Assay (28 days, -229 days)

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Neurology

Average 510(k) decision time: 163 days

• K241390 Lvis Corporation - Neuromatch (195 days, +32 days)
• K240575 Eemagine Medical Imaging Solutions Gmbh - Waveguard Net Eeg Cap (Na-245, Na-255, Na-261, Na-265, Na-271, Na-281) (269 days, +106 days)

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Obstetrics/Gynecology

Average 510(k) decision time: 177 days

• None

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Ophthalmic

Average 510(k) decision time: 177 days

• None

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Orthopedic

Average 510(k) decision time: 121 days

• ?? K243375 Ruthless, Llc Dba Ruthless Spine - Ruthless Spine Rjb (30 days, -91 days)
• K242187 Conmed Corporation - Biobrace? (125 days, +4 days)
• K243408 Vilex Llc - Tactix Vector Syndesmosis System (26 days, -95 days)
• K231655 Solco Biomedical Co., Ltd. - 4Cis? Chiron Spinal Fixation System (539 days, +418 days)
• K243191 Atlas Spine, Inc. - Atlas Spine Lateral Expandable Interbody System (57 days, -64 days)
• ?? K241995 Footbridge Medical - Hyperflex? Bunion Correction System (140 days, +19 days)
• K242494 Riverpoint Medical Llc - Osseofit Interfacing Anchor; Osseofit Bone Tunnel Construct (96 days, -25 days)
• ?? K242631 Smith & Nephew Inc., Endoscopy Div. - Regeneten? Bioinductive Implant (84 days, -37 days)
• K243050 Trimed, Inc. - Trimed Posterior Malleolus Fixation System (60 days, -61 days)
• K242253 Fh Industrie - Jarvis Glenoid Reverse Shoulder Prosthesis (117 days, -4 days)
• K243162 Signature Orthopaedics Pty Ltd - World Liner (56 days, -65 days)

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Pathology

Average 510(k) decision time: 295 days

• None

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Physical Medicine

Average 510(k) decision time: 164 days

• K243355 Ceragem Co, Ltd. - Ceragem Automatic Thermal Massager (Cgm-Mb-1902) (29 days, -135 days)
• K242308 Zhejiang Zhonglei Medical Technology Co. Ltd. - Power Wheelchair (114 days, -50 days)
• K241588 Zhejiang Kairui Medical Device Co., Ltd - Electric Wheelchair (Kr8803) (175 days, +11 days)
• K232982 Shandong Huamei Technology Co.,Ltd. - Ems Sculpt Machine (430 days, +266 days)

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Radiology

Average 510(k) decision time: 145 days

• K242444 Samsung Medison Co., Ltd. - Hera W10 Diagnostic Ultrasound System; Hera W9 Diagnostic Ultrasound System (103 days, -42 days)
• K243221 Eizo Corporation - Radiforce Rx570; Radiforce Rx570-Ar (51 days, -94 days)
• K240645 Ontact Health Co., Ltd - Sonix Health (265 days, +120 days)
• K242961 Varian Medical Systems - Intraluminal Applicator Set (62 days, -83 days)
• K242258 Asg Superconductors S.P.A. - Mropen Evo (03-2000-00); Mropen Evo (03-4000-00) (118 days, -27 days)
• ?? K242810 Radunity Corp. - Radunity (Version 1.0.0) (69 days, -76 days)
• K241831 Screenpoint Medical B.V. - Transpara (2.1.0) (153 days, +8 days)

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