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 2026-10-12, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,969 of the 176,366 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	2,569

176,366 records, page 3244 of 3528

510(k) clearances, page 3244 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K820313	Vpi-Fair Urethral Stent	Vance Products, Inc.	KOD	Class II	1982-03-01
K820312	H-H Rickham Type Reservoir	Holter-Hausner Intl.	JXG	Class II	1982-03-01
K820293	Bone Biopsy Set	The Anspach Effort, Inc.	KNW	Class II	1982-03-01
K820135	Taylor & Tycos Acoustic Sphygmomanometer	Sybron Corp.	DXN	Class II	1982-03-01
K820123	Sunflower	Solana, Inc.	FTC	Class II	1982-03-01
K820122	Pioneer II Back Plate Electrode	Life Science Instrumentation, Inc.	DRX	Class II	1982-03-01
K820013	Titanium Implant Devices	Bofors Nobelpharma, Inc.	DZE	Class II	1982-03-01
K813641	Vital Metrics Urine Monitoring System	Vital Metrics, Inc.	FFG	Class II	1982-03-01
K813462	Madayag Type Needle	Ocean Medical Products, Ltd.	KNW	Class II	1982-03-01
K813398	Ssd-203 Ultrasonic Scanner	U. S. A. Imaging Corp.	IYO	Class II	1982-03-01
K813371	Grosse and Kempf Locking Nail Sys.	Howmedica Corp.	HSB	Class II	1982-03-01
K813315	Caliper-Opthalmic	Design Research Assoc., Inc.	HOE	Class I	1982-03-01
K813313	Biomicroscopy Contact Lens	Design Research Assoc., Inc.	HJO	Class II	1982-03-01
K813002	Mavis C	Philips North America LLC	DXK	Class II	1982-03-01
K812995	Vance-Jacobellis Microhematuria Catheter	Vance Products, Inc.	KOD	Class II	1982-03-01
K827086	Lateral Angulating Fluoro Suspension	General Electric Co.			1982-02-24
K827064	Siemens Polydoros 800	Siemens Medical Solutions USA, Inc.			1982-02-24
K820383	Finger Cot	Conco Medical Co.	ILH	Class I	1982-02-24
K820311	H-H Burr Hole Catheter Support	Holter-Hausner Intl.	JXG	Class II	1982-02-24
K820302	Surgipeel Self-Seal Packaging System	Surgicot, Inc.	FRG	Class II	1982-02-24
K820277	Gdc-1130	Deringer-Ney, Inc.	EJT	Class II	1982-02-24
K820216	Ultra-Wet	Buffalo Dental Mfg Co Inc	ELW	Class II	1982-02-24
K820184	Lateral Angulating Fluoro Suspension	General Electric Co.	JAA	Class II	1982-02-24
K820183	Sybron/kerr Mirror 3	Sybron Corp.	ELW	Class II	1982-02-24
K820181	Sybron/kerr Contour	Sybron Corp.	EJJ	Class II	1982-02-24
K820172	Phonic Ear Model Pe 810S	Phonic Ear, Inc.	ESD	Class I	1982-02-24
K820168	Mentor Activator Neuromuscular Stimu	Mentor	IPF	Class II	1982-02-24
K820164	Empty Sterile Carpuject	Sterling Drug, Inc.	FMF	Class II	1982-02-24
K820162	Tec-Son II	California Technics, Inc.	ELC	Class II	1982-02-24
K820112	Siemens Polydoros 800	Siemens Corp.	IZO	Class I	1982-02-24
K820101	Sharplan 720 CO2 Surgical Laser	Laser Industries, Ltd.	GEX	Class II	1982-02-24
K820092	Secure-on-Touch	Sci-Pharm, Inc.	DYH	Class II	1982-02-24
K820091	Airmed Smoke Evacuation & Filter	James L. Geraci & Associates, Inc.	CIE	Class II	1982-02-24
K820050	Kremer Blade Gauge	Accutome, Inc.	HOE	Class I	1982-02-24
K820023	Conagraf Tm Durapatite Cones	Sterling Drug, Inc.	LYC	Class II	1982-02-24
K813619	Conphar-Schioetz Tonometer	Conphar, Inc.	HKY	Class II	1982-02-24
K813569	Emotens	Electro Medica Office	GZJ	Class II	1982-02-24
K813550	Hybrid Dental Product	Dentsply Intl.	EBH	Class I	1982-02-24
K813543	Adr Ultrasound Models 4000S & 4000S/l	Adr Ultrasound	IYO	Class II	1982-02-24
K813380	Cavidentin	Bitan Int'L Marketing Co.	EMA	Class II	1982-02-24
K813328	Myerson/kenson Gp Polymer	Howmedica Corp.	EBD	Class II	1982-02-24
K813314	Nld Implant Set	Design Research Assoc., Inc.	HMX	Class I	1982-02-24
K812320	Air Alive	Western Systems, Inc.	FRF	Class II	1982-02-24
K820339	Islam Bone Marrow Biopsy Needle	Downs Surgical, Ltd.	GDM	Class I	1982-02-23
K820332	Needle & Blade Counter	Abco Dist.	FSM	Class I	1982-02-23
K820331	Impact, Model 302	ZOLL Medical Corporation	JCX	Class II	1982-02-23
K820330	Impact, Model E-12	ZOLL Medical Corporation	JCX	Class II	1982-02-23
K820324	Emit and Netilmicin Assay	Syva Co.	LCE	Class II	1982-02-23
K820323	Emit and Netilmicin Control	Syva Co.	LAS	Class I	1982-02-23
K820286	Syva Advance Sy. Emit-Amd Gent. Control	Syva Co.	LAS	Class I	1982-02-23