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 1975 of 3531

510(k) clearances, page 1975 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K961726	Abuscreen Online Cannabinoids Calibration Pack 20	Roche Diagnostic Systems, Inc.	DLJ	Class II	1996-07-11
K961562	Osteomark	Ostex Intl., Inc.	JMM	Class I	1996-07-11
K955834	System 6500 Abc Electrosurgical Unit	Aspen Laboratories, Inc.	GEI	Class II	1996-07-11
K955755	Trend Cryptosporidium Detection Test Systems	Trend Scientific, Inc.	MHJ	Class II	1996-07-11
K955045	Omni-Trak Patient Monitoring System	Invivo Research, Inc.	DPS	Class II	1996-07-11
K954773	Quickels Qs 100 System	Ferguson Medical	DRX	Class II	1996-07-11
K954772	Quickels Qs 200 System	Ferguson Medical	DRX	Class II	1996-07-11
K954163	Retrospective II-Elite ECG Memory Loop Recorder	Cardiac Evaluation Center, Inc.	DXH	Class II	1996-07-11
K962523	N Latex Crp Mono Reagent	Behring Diagnostics, Inc.	DCK	Class II	1996-07-10
K962183	Brand Name 1-Step Pregnancy Test-May Be Marketed Under First Response, Answer, or Other Brand Names	Armkel, LLC	LCX	Class II	1996-07-10
K961940	Innerdyne Step Trocar Expandable Port, Onestep	Innerdyne, Inc.	GCJ	Class II	1996-07-10
K961913	Quanta Lite Ena 6 Elisa	Inova Diagnostics, Inc.	LLL	Class II	1996-07-10
K961819	Streptomycin Disk (300Mcg)	Remel Inc	JTN	Class II	1996-07-10
K961818	Gentamicin Disk (120Mcg)	Remel Inc	JTN	Class II	1996-07-10
K961754	Safety Release Module	G & H Wire Company	DZB	Class II	1996-07-10
K961737	Cera One Abutment System	Nobelpharma USA, Inc.	DZE	Class II	1996-07-10
K961728	Miruscone Abutment System	Nobelpharma USA, Inc.	NHA	Class II	1996-07-10
K961685	P.f.c. Cruciate Retaining Knee System (Size 1.5)	Johnson & Johnson Professionals, Inc.	JWH	Class II	1996-07-10
K961585	Surgical Dynamics Pop Rivet	United States Surgical, A Division of Tyco Healthc	JDR	Class II	1996-07-10
K961579	Sta Compact Automated Multi-Parametric Analyzer	American Bioproducts Co.	GKP	Class II	1996-07-10
K961578	Suture Anchor	United States Surgical, A Division of Tyco Healthc	JDR	Class II	1996-07-10
K961555	Acufex Tag Bioabsorbable Anchors	Acufex Microsurgical, Inc.	JDR	Class II	1996-07-10
K961507	Walstent Tracheobronchial Endoprosthesis	Boston Scientific Corporation	JCT	Class II	1996-07-10
K961424	Intran 500	Utah Medical Products, Inc	HFN	Class II	1996-07-10
K961362	Aerotel Telelink ECG Telephonic Receiving Interface	Aerotel Ltd.	DXH	Class II	1996-07-10
K961340	Nova Lite Anca	Inova Diagnostics, Inc.	MOB	Class II	1996-07-10
K961296	Wallstent Tracheobronchial Endoprosthesis	Boston Scientific Corporation	JCT	Class II	1996-07-10
K961243	Ocusystem Art Advantage	Surgical Design Inc	HQC	Class II	1996-07-10
K961133	Somnus Medical Tech. Malleable Coagulating Electrode	Somnus Medical Technologies, Inc.	GEI	Class II	1996-07-10
K960769	Acupuncture Needle Pack	Acu Med, Inc.	MQX	Class II	1996-07-10
K955821	i.v. Administration Sets	Medical Associates Network, Inc.	FPA	Class II	1996-07-10
K955799	Copalis Cmv Total Antibody Assay	Sienna Biotech, Inc.	LJO	Class II	1996-07-10
K955088	Neosono 2000	American Medical & Dental Corp.	LQY	Unclassified	1996-07-10
K954290	Wallstent Enteral Endoprothesis	Boston Scientific Corporation	MQR	Class II	1996-07-10
K954065	Biodata Sr1 Fah-Hcg Enzyme Immunoassay Kit	Biochem Immunosystems (U.S.), Inc.	JHI	Class II	1996-07-10
K962147	Dexterity Pneumo Sleeve Set	Medical Creative Technologies, Inc.	GCJ	Class II	1996-07-09
K962024	S-57 Video Imaging System	Del Medical Systems Corp.	FET	Class II	1996-07-09
K961934	Puritan Foam Tip Swab Model 2197	Hardwood Products Co., LP	HHT	Class II	1996-07-09
K961589	Apr Fully Textured Hip Stem	Intermedics Orthopedics	LZO	Class II	1996-07-09
K961568	Ed-344Ot	Pentax Precision Instrument Corp.	FDT	Class II	1996-07-09
K961564	Eg-2940, Video Gastroscope	Pentax Precision Instrument Corp.	FDS	Class II	1996-07-09
K961483	Duracon All Polyethylene Patella II	Howmedica Corp.	JWH	Class II	1996-07-09
K961445	Radifocus Glidewire for Coronary Use with Platinum (or Gold) Coil	Terumo Medical Corp.	DQX	Class II	1996-07-09
K961391	Flexart Qd Head/neck Coil	Toshiba America Mri, Inc.	MOS	Class II	1996-07-09
K960555	Bioasbsorbable Mini-Screw Suture Anchor	Instrument Makar, Inc.	MAI	Class II	1996-07-09
K955612	Rd-1200H Normal Mode Ruby Laser System	Spectrum Medical Technologies, Inc.	GEX	Class II	1996-07-09
K955597	Medi-Trace Defib Pads	Graphic Controls Corp.	GYB	Class II	1996-07-09
K962211	Ubi Magiwel Thyroxine (T4) Quantitative	United Biotech	KLI	Class II	1996-07-08
K961703	Colleague 2 Volumetric Infusion Pump(dual Channel)/colleague 3 Volumetric Infusion Pump(tree Channel)	Baxter Healthcare Corporation	FRN	Class II	1996-07-08
K961678	Human Growth Hormone Immunoassay Kit	Nichols Institute Diagnostics	CFL	Class I	1996-07-08