510(k) clearances

Premarket notifications cleared by FDA, newest decision first.

Every 510(k) record MDM has ingested from openFDA. Each clearance page carries the record as FDA published it, the product code it was cleared under, recalls sharing that product code, and a link to the FDA source.

Data as of 2026-11-05, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,132 of the 176,529 ingested clearances have a decision year between 2012 and 2026, the 15 years shown, 2023 the highest year at 3,346.

Show the numbers

510(k) clearances by decision year, the last 15 years of ingested records
Year	Clearances
2012	3,135
2013	3,052
2014	3,202
2015	3,020
2016	2,956
2017	3,200
2018	3,062
2019	2,918
2020	2,923
2021	3,023
2022	3,209
2023	3,346
2024	3,129
2025	3,225
2026	2,732

176,529 records, page 2104 of 3531

510(k) clearances, page 2104 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K935676	Micro Rsh High Speed Handpiece	Micro Motors, Inc.	EFB	Class I	1995-03-31
K926364	Attest Brand Rapid Readout Biological Ind. #129X	3M Company	FRC	Class II	1995-03-31
K950902	Alko Tonometered Saline Control	Alko Diagnostic Corp.	JJS	Class I	1995-03-30
K950801	Cardio Rep Ld Control - Cat No. 3325	Helena Laboratories, Corp.	JJT	Class I	1995-03-30
K950590	Rep Cholesterol Profile Control	Helena Laboratories, Corp.	JJX	Class I	1995-03-30
K950496	Snare, Flexible, Electrosurgical Cutting & Coagulation Device & Accessories	Boston Scientific Corporation	FDI	Class II	1995-03-30
K950400	Hand Massage Unit	Ultrassage, Inc.	IRO	Class I	1995-03-30
K950135	Urine Amphetamines Screen Flex(tm) Reagent Cartridge	E.I. Dupont de Nemours & Co., Inc.	DKZ	Class II	1995-03-30
K950016	Cart, Mode Number Uds-Cart	Laborie Medical Tech Corp.	FEN	Class II	1995-03-30
K946387	Capra (Caprac-R) Wipetest and Well Counter	Mirion Technologies (Capintec), Inc.	JJJ	Class I	1995-03-30
K945211	Karl Storz Retractore, Probes, Dissectors, Hooks, Uterineelevators, Uterine Cannulae	Karl Storz Endoscopy-America, Inc.	HET	Class II	1995-03-30
K942091	Ohmeda Tec 5 Vaporizer for Use with Sevoflurane	GE Healthcare	CAD	Class II	1995-03-30
K935449	Foundation Non-Porous Stem	Encore Orthopedics, Inc.	JDI	Class II	1995-03-30
K934178	Accuscreen 17-Hydroxyprogesterone	Neometrics, Inc.	JLX	Class I	1995-03-30
K932769	Camino Ventricular Drainage System	Camino Laboratories, Inc.	JXG	Class II	1995-03-30
K950985	Zeiss Endolive Stero Endoscope	Carl Zeiss, Inc.	GCJ	Class II	1995-03-29
K950737	Landmark Midline Catheter	Menlo Care, Inc.	FOZ	Class II	1995-03-29
K950581	Smart Anesthesia Multi-Gas (Sam) Module	Marquette Electronics, Inc.	CCK	Class II	1995-03-29
K950491	Rich-Mar Carbon Electrodes	Rich-Mar Corp.	GXY	Class II	1995-03-29
K950434	Karl Storz Flexible Grasping, Biopsy Forceps, Stone Baskets, Dislodgers, Scissors, Injection Cannulae, Cleaning Brushes	Karl Storz Endoscopy-America, Inc.	OCZ	Class II	1995-03-29
K950414	Hemagen Ena Sm/rmp Kit (Eia Method)	Hemagen Diagnostics, Inc.	LLL	Class II	1995-03-29
K950277	Insurg Laptie Plus Suture Ligator with Needle Driver	Boston Scientific Corporation	GCJ	Class II	1995-03-29
K946338	Certiburn Burn/trauma Face Dressing, Towel Dressing	Certified Safety Mfg Inc	MGP	Unclassified	1995-03-29
K945977	Centurion(r) Site Guard(r) Transparent Dressing/transpaent Film Dressing	Centurion Medical Products, LP	MGP	Unclassified	1995-03-29
K945720	Jostra Hl-15 Modular Heart-Lung Machine (Hereinafter Called the Hl-15 or the Device	Jostra Bentley	DWC	Class II	1995-03-29
K945616	Cordis Avanti Catheter Sheath Introducer	Cordis US Corp.	DYB	Class II	1995-03-29
K944968	Landmark Midline Catheter	Menlo Care, Inc.	FOZ	Class II	1995-03-29
K944824	Surewing	Gainor Medical U.S.A., Inc.	FPA	Class II	1995-03-29
K944158	Steri-Oss Titanium Alloy Screw Series Implant for Single Stage Surgical Placement	Steri-Oss, Inc.	DZE	Class II	1995-03-29
K943603	Aesculap Laparoscopic Ancillary Devices	Aesculap Inc	HET	Class II	1995-03-29
K936047	Spectrum(tm) Mask	Respironics, Inc.	BZD	Class II	1995-03-29
K931133	Clinical Infor Syst(cis) W/fetal Monit Remote Disp	Clinicomp, Inc.	HGM	Class II	1995-03-29
K950811	Karl Storz Fiber Optic Ligh Cables	Karl Storz Endoscopy-America, Inc.	GCJ	Class II	1995-03-28
K950797	Halogen Ophthalmo-Otoscope Set Bx a - 134	Neitz Instruments Company, Ltd.	HLJ	Class II	1995-03-28
K950795	Streak Retinoscope Rx-Rp	Neitz Instruments Company, Ltd.	HKM	Class I	1995-03-28
K950794	Streak Retinoscope Rx-Rc	Neitz Instruments Company, Ltd.	HKM	Class I	1995-03-28
K950793	Spot Retinoscope Rx-3Sp	Neitz Instruments Company, Ltd.	HKM	Class I	1995-03-28
K950792	Streak Retinoscope Rx-3A	Neitz Instruments Company, Ltd.	HKM	Class I	1995-03-28
K950791	Streak Retinoscope Rx-3	Neitz Instruments Company, Ltd.	HKM	Class I	1995-03-28
K950789	Streak Retinoscope Rx-1	Neitz Instruments Company, Ltd.	HKL	Class II	1995-03-28
K950165	Interpore Ip 200 Granular Coralline Hydroxyapatite Bone Void Fillers, 425 to 1000 Microns and 425 to 600 Microns	Interpore Intl.	LYC	Class II	1995-03-28
K950083	Multiple	Commonwealth Optical Manufactory Ltd.	HQY	Class I	1995-03-28
K946328	Tdx(r)/tdxflx(r) Phenytoin II	Abbott Medical	LGR	Class II	1995-03-28
K945656	The Coupler/drape(tm), Video Camera Sterile Drape	Micro Medical Devices, Inc.	KKX	Class II	1995-03-28
K944765	Karl Storz Insulated Biopsy Forceps, Grasping/dissecting Forecps, Flexible Forceps	Karl Storz Endoscopy-America, Inc.	KGE	Class II	1995-03-28
K944313	Spectacle Frame	Sun Hing Optical Manufactory Ltd.	HQZ	Class I	1995-03-28
K942931	Statlock Securement Devices	Venetec, Inc.	FPA	Class II	1995-03-28
K942483	Clinical Glass Thermometer	Makol Medical Instruments Corp.	FLK	Class II	1995-03-28
K932866	Resolut Regenerative Material	W. L. Gore & Associates, Inc.	LYC	Class II	1995-03-28
K924997	Edd	Arc Medical, Inc.	BTR	Class II	1995-03-28