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 1817 of 3531

510(k) clearances, page 1817 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K980766	Osteonics Anteverted Neck Ha Hip Stems	Osteonics Corp.	MEH	Class II	1998-05-27
K980407	Hope Nebulizer	B & B Medical Technologies, Inc.	CAF	Class II	1998-05-27
K980347	Etest Tetracycline	Ab Biodisk	JWY	Class II	1998-05-27
K980345	Etest Ceftriaxone	Ab Biodisk	JWY	Class II	1998-05-27
K980193	Manan General Utility Drainage Catheter	Medical Device Technologies, Inc.	LJE	Unclassified	1998-05-27
K980192	Manan Nephrostomy Drainage Catheter	Medical Device Technologies, Inc.	LJE	Unclassified	1998-05-27
K981292	Quikpac II One Step Phencyclidine (Pcp) Test	Syntron Bioresearch, Inc.	LCM	Unclassified	1998-05-26
K981206	Tas Results Data Acquisition System (Traqs)	Cardiovascular Diagnostics, Inc.	GKP	Class II	1998-05-26
K981200	Il Test Plasminogen	Instrumentation Laboratory Co.	GGP	Class II	1998-05-26
K981099	Stratus Cs Stat Fluorometric Analyzer and Stratus Cs Ckmb Testpak	Siemens Healthcare Diagnostics Inc.	JHX	Class II	1998-05-26
K981061	Intravascular Retrieval Device	Med Institute, Inc.	GCC	Class I	1998-05-26
K981043	Dialysol-Acid Concentrate Liquid, Granusol-Acid Concentrate Powder, Renalsol-Acetate Concentrate Liquid & Powder, Biosol	Solution Technologies	KPO	Class II	1998-05-26
K980746	Cedia Dau Eddp Assay	Boehringer Mannheim Corp.	DJR	Class II	1998-05-26
K980739	Histofreezer/ 17% Salicylic Acid-Verruca Plantaris	OraSure Technologies, Inc.	GEH	Class II	1998-05-26
K974596	Dimertest Latex Assay	Agen Biomedical, Ltd.	DAP	Class II	1998-05-26
K974488	Airprep System - Model 9001	ASI Medical, Inc.	KOJ	Class II	1998-05-26
K974123	Branemark System Dec 600 Drilling Unit	Nobel Biocare Uas, Inc.	DZE	Class II	1998-05-26
K973545	Vacu*med Gold Edition Oxygen Gas Analyzer	Vacumed, Div. of Vacumetrics, Inc.	CCL	Class II	1998-05-26
K973544	Vacu*med, Gold Edition Carbon Dioxide Gas Analyzer	Vacumed, Div. of Vacumetrics, Inc.	CCK	Class II	1998-05-26
K973360	Medtronic Model 6416 Transvenous Bipolar Temporary Pacing Lead	Medtronic, Inc.	LDF	Class II	1998-05-26
K981341	Stc Opiates Micro-Plate Eia (Orasure Application)	OraSure Technologies, Inc.	DJG	Class II	1998-05-22
K981211	Apr -T Revision Hip Stem	Sulzer Orthopedics, Inc.	LPH	Class II	1998-05-22
K981037	Clear (Tm) Special Nit Comb	Care Technologies, Inc.	LJL	Class I	1998-05-22
K980858	Multitest Cd3/cd16+56/cd45/cd19 Reagent and Multitest Imk Kit Lysing Solution	Becton Dickinson Immunocytometry Systems	GKZ	Class II	1998-05-22
K980788	Alphatec Wire External Fixation System	Alphatec Spine, Inc.	JDW	Class II	1998-05-22
K980781	Implex Continuum Knee- Hedrocel Revision Femoral Spacers	Implex Corp.	JWH	Class II	1998-05-22
K980731	Accu-Chek Comfort Curve Test Strips	Boehringer Mannheim Corp.	LFR	Class II	1998-05-22
K980717	Uromed Sling Kit	Uromed Corp.	KNA	Class II	1998-05-22
K980713	Femoral and Tibial Plugs of Interax Total Knee System	Howmedica Corp.	JWH	Class II	1998-05-22
K980710	Schwartz Electro-Optics, Inc. Crystalase 755 Dp Alexandrite Laser System	Schwartz Electro-Optics, Inc.	GEX	Class II	1998-05-22
K980690	Cable Screw with Integral Crimp	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)	JDQ	Class II	1998-05-22
K980687	Sonos 5500 Ultrasound Imaging System	Hewlett-Packard Co.	IYO	Class II	1998-05-22
K974882	Downscan Lt	Merlin Engineering Works, Inc.	LMD	Class I	1998-05-22
K974245	Depuy Ace Ring Skull Pins-MRI, Depuy Ace Spring Loaded Tong Pin-MRI, Depuy Ace Fixed Tip Tong Pin-MRI	Depuy Ace Medical Co.	LXT	Class II	1998-05-22
K981091	Neocolloid, Orthoprint	Zhermack S.p.A.	ELW	Class II	1998-05-21
K980676	Spigal Needle	Gallini U.S., LLC	KNW	Class II	1998-05-21
K980673	Spyrosorb Foam Island Wound Dressing	Innovative Technologies (Us), Inc.	KMF	Class I	1998-05-21
K980401	Flexible Fiberscopes and Accessories	Richard Wolf Medical Instruments Corp.	FAJ	Class II	1998-05-21
K974695	Cobras Integra Acid Prostatic Phosphatase (Acpp) Cobad Integra Benzodiazepines with B-Glucuronidase (Bnzgl)	Roche Diagnostic Systems, Inc.	CKB	Class II	1998-05-21
K974571	Solution Administration Set with Capped Luer Activated Valve	Baxter Healthcare Corporation	FPA	Class II	1998-05-21
K974141	Plus Reusable Resuscitator	Schiff & Co.	BTM	Class II	1998-05-21
K973929	Neotonus Ms-101 Magnetic Muscle Stimulator System	Neotonus, Inc.	IPF	Class II	1998-05-21
K973840	Fast-Cath (Tm) Intra-Cardiac Introducer	Daig Corp.	DYB	Class II	1998-05-21
K970968	Bissinger Detachable Bipolar Coagulation-Forceps	Guenter Bissinger Medizintechnik GmbH	HET	Class II	1998-05-21
K981460	Cub Dis II Dpoae Measurement System	Mimosa Acoustics, Inc.	EWO	Class II	1998-05-20
K981458	Ksea Rhino-Laryngo-Broncho-Fiberscope,pediatric Broncho-Fiberscope, and Broncho-Fiberscope,11001rk, 11002Bc & 110	Karl Storz Endoscopy-America, Inc.	EOB	Class II	1998-05-20
K981452	Osteonics Long Arm Containment Ring	Osteonics Corp.	KWP	Class II	1998-05-20
K981423	Autogenesis Automator 2000 Model Number Sc2000	Autogenesis, Inc.	JEC	Class II	1998-05-20
K981407	Opta Lp Pta Balloon Catheter/powerflex Plus Pta Balloon Catheter	Cordis US Corp.	LIT	Class II	1998-05-20
K981404	Fukuda Denshi Ultrasound Scanners Models Uf-3500 and Uf-4500	Fukuda Denshi USA, Inc.	IYO	Class II	1998-05-20