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 2026-10-26, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 2819 of 3530

510(k) clearances, page 2819 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K871022	Precimat(r) Transferrin	Boehringer Mannheim Corp.	DDG	Class II	1987-05-14
K871011	Simpson Peripheral Atherocath(tm)	Devices for Vascular Intervention, Inc.	LIT	Class II	1987-05-14
K870965	Ciba Corning Magic(r) Lite T4 Immunoassay	Ciba Corning Diagnostics Corp.	CDX	Class II	1987-05-14
K870903	Immustrip(tm) Dsdna Elisa Test System	Immunomedics, Inc.	LRM	Class II	1987-05-14
K870858	Badgwell Sampling Catheter	Dryden Corp.	CCK	Class II	1987-05-14
K870707	Pentamax 1 Model B Table System	Spectrum X-Ray Corp.	IXR	Class II	1987-05-14
K870654	Efer Arthroscope	Roseburg SA	HRX	Class II	1987-05-14
K870652	Medtronic Model 4220 Ambulatory ECG Monitor	Medtronic, Inc.	DXH	Class II	1987-05-14
K870181	Johnson Intratracheal Oxygen Catheter Set	Cook Inc.	BTO	Class II	1987-05-14
K871640	Alkaline Peptone Water	BD Becton Dickinson Vacutainer Systems Preanalytic	JSD	Class I	1987-05-13
K871613	Buffalo Green Monkey Kidney Cells	Viromed Laboratories, Inc.	KIR	Class I	1987-05-13
K871447	Todd Hewitt W/cna (Lim Broth)	Remel Inc	JSD	Class I	1987-05-13
K871240	Abbott a-Gent Ld-1 Isozyme Reagent	Abbott Medical	JGF	Class II	1987-05-13
K871105	The Gonogen II Test Kit for Neisseria Gonorrhoeae	New Horizons Diagnostics Co.	LIC	Class II	1987-05-13
K870128	Hartford Total Hip System (Tri-Wedge)	Richards Medical Co., Inc.	JDI	Class II	1987-05-13
K871677	Creatine Kinase for Continuous Flow Instruments	Catachem, Inc.	JHY	Class II	1987-05-12
K871651	Colorimetric Bun Reagent Kit	Biochemical Trade, Inc.	CDL	Class II	1987-05-12
K871650	Glucose Enzyme - Color Reagent Set	Biochemical Trade, Inc.	CGA	Class II	1987-05-12
K871644	Delfia (Tm) Htsh Kit	Lkb Instruments, Inc.	JLW	Class II	1987-05-12
K871642	Tampax Tampon, Regular	Tambrands Inc.	HEB	Class II	1987-05-12
K871638	Easy-Test Chem Cal Levels 1,2&3/Items 67617 Abc/95	Em Diagnostic Systems, Inc.	JIX	Class II	1987-05-12
K871412	Contour Soft-E Series Conductive Solid Gel Electro	Contour Electrodes, Inc.	DRX	Class II	1987-05-12
K871329	Easy-Test Emit Gentamicin (Gent) Item No. 16640	Em Diagnostic Systems, Inc.	LCD	Class II	1987-05-12
K871294	Acu-Preg-Al Slide Test	Papibris Scientific, Inc.	JHJ	Class II	1987-05-12
K871197	Playtex Tampons and Deodorant Tampons	Intl. Playtex, Inc.	HIL	Class II	1987-05-12
K871136	Heartstart 2000, Manual Defibrillator	First Medical Devices Corp.	LDD	Class II	1987-05-12
K871135	Heartstart 2000, Manual Medical Control Module	First Medical Devices Corp.	LDD	Class II	1987-05-12
K871130	Contact Lens Tweezers	S. M. C. Medi-Tech Corp.	KYE	Class I	1987-05-12
K870677	Ney-Oro 41	Deringer-Ney, Inc.	EJT	Class II	1987-05-12
K870657	Avl Model 985 Electrolyte Analyzer	Avl Scientific Corp.	CEM	Class II	1987-05-12
K870221	T.o.p. 2000 (Tomographic Orientated Planning)	Kermath Mfg. Corp.	KPQ	Class II	1987-05-12
K870196	Pcte Microporous Membrane Filter	Poretics Corp.	KET	Class I	1987-05-12
K870183	Ionometer Ef and Accessories	Smash Ent., Inc.	JGS	Class II	1987-05-12
K870035	Kodak Ektachem Dt Slides (Ca)	Eastman Kodak Company	CID	Class II	1987-05-12
K864568	40Cc Surgical Double Lumen Balloon Catheter	Aries Medical, Inc.	DSP	Class II	1987-05-12
K864567	40Cc Percutaneous Furl Dou. Lumen Balloon Catheter	Aries Medical, Inc.	DSP	Class II	1987-05-12
K864429	Dsp100 Carotid Phonoangiography Module	Intl. Acoustics, Inc.	DQC	Class I	1987-05-12
K871475	Sololift - Patient Transfer Stretcher	Adel Medical, Ltd.	FMR	Class I	1987-05-11
K871465	Thermometer Sheaths	Abco Dealers, Inc.	FLL	Class II	1987-05-11
K871435	Bard Ems System 6000 E.s.u.	C.R. Bard Inc	HAM	Class II	1987-05-11
K871073	Omega Bivalve Nasal Splints	Omega Silicone, Inc.	FYI	Class I	1987-05-11
K871070	Omega Silicone Chin Implant	Omega Silicone, Inc.	FWP	Class II	1987-05-11
K870508	Gastrointestinal Tube	Penn Medical Devices, Inc.	KNT	Class II	1987-05-11
K870419	Ivr-Sp Custom Angiography Tray	North Coast Medi-Tek	DQO	Class II	1987-05-11
K870328	Single Lumen Acute Catheter	Quinton, Inc.	LFJ	Class II	1987-05-11
K865035	Record Keeping/data Management System	Critical Care Systems, Inc.	DQK	Class II	1987-05-11
K864980	3Mhz Annular Array	Philips North America LLC	JOP	Class II	1987-05-11
K864583	Cardiac Performance Monitor	Vascular Technology Incorporated	DQK	Class II	1987-05-11
K864260	Applicard System (ECG Electrode System)	Grandcor Medical Systems	DRX	Class II	1987-05-11
K862282	Rapidex Biological Surfactant	Rapidex of London	FLG	Class I	1987-05-11