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 2204 of 3531

510(k) clearances, page 2204 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K935221	Stryker Arthroscopic Manual Surgical Instruments	Stryker Corp.	HRX	Class II	1994-04-28
K934909	Cobalt Chrome Gemini	Depuy, Inc.	LWJ	Class II	1994-04-28
K934545	Ps Medical Delta Burr Hole Valve	Pudenz-Schulte Medical Research Corp.	JXG	Class II	1994-04-28
K934371	Bip Multi Modification	Bip USA, Inc.	KNW	Class II	1994-04-28
K933501	Alastik	Unitek Corp.	EJF	Class I	1994-04-28
K933418	Hand Therapy Assost	Bardon Ent., Inc.	JFA	Class I	1994-04-28
K932243	Gallor Dental Material & Coping Intracast Technolo	Precious Chemicals U.S.A., Inc.	EJT	Class II	1994-04-28
K931652	Ace 6.5 Mm Bone Screw	Ace Medical	HWC	Class II	1994-04-28
K931396	Dental Screw Posts	Harald Nordin S.A.	ELR	Class I	1994-04-28
K931323	Mountable Knife	Esco Medical	HRX	Class II	1994-04-28
K931113	Cadd-Tpn(tm) Ambulatory Infusion System	Pharmacia Deltec, Inc.	FIH	Class II	1994-04-28
K930416	Surgical Suture Package Inserts	United States Surgical, A Division of Tyco Healthc	GAL	Class II	1994-04-28
K925968	Endoscope	United States Surgical, A Division of Tyco Healthc	HET	Class II	1994-04-28
K924792	Multiple Purpose Forceps	Nusurg, Inc.	GCJ	Class II	1994-04-28
K941659	Aural-Cam, Video Ear, Vid Rx	Gracefully Yours, Inc.	ERA	Class I	1994-04-26
K941569	Caremor Cliner	Winco, Inc.	INM	Class I	1994-04-26
K941400	Synermed Ise Reagents	Synermed, Inc.	JGS	Class II	1994-04-26
K941156	Technison Axon System	Miles, Inc.	KHS	Class II	1994-04-26
K941042	Cedia T4 Mab Assay	Microgenics Corporation	KLI	Class II	1994-04-26
K940891	Tecnadyne Endoscopic Instrument Holder	Tecnadyne Scientific, Inc.	GCJ	Class II	1994-04-26
K940702	Convertors Opti-Sorb Drape Material	Baxter Healthcare Corporation	KKX	Class II	1994-04-26
K940623	Acufex Suretac Ixc Systems	Acufex Microsurgical, Inc.	HRX	Class II	1994-04-26
K940578	Manual Stetoscope	Bhs Intl., Inc.	LDE	Class I	1994-04-26
K940506	Acufex Arthroscopic Suture Cutter	Acufex Microsurgical, Inc.	HRX	Class II	1994-04-26
K940482	Ciba Corning Acs Ft3 Immunoassay	Ciba Corning Diagnostics Corp.	CEC	Class II	1994-04-26
K940221	Access Cortisol Reagents	Bio-Rad Laboratories Inc.	CGR	Class II	1994-04-26
K940142	Glycated Protein Controls	Trinity Biotech (Primus Corporation dba Trinity Biotech)	JJX	Class I	1994-04-26
K936258	System Washer 100	Eg&G Berthold	JQW	Class I	1994-04-26
K936088	Wave Fluorescent Magnifier	Burton Medical Products Corp.	KZF	Class I	1994-04-26
K936044	Enhanced Modular Austin Moore Hip	Zimmer GmbH	KMC	Class II	1994-04-26
K935806	Immulite Dhea-S04	Siemens Healthcare Diagnostics Inc.	JKC	Class I	1994-04-26
K935728	Dynatron 150	Dynatronics Corp.	IMG	Class II	1994-04-26
K935666	Perkin-Elmer Series 200 Liq Chromatographic Pump	Revvity Health Sciences, Inc.	KIE	Class I	1994-04-26
K935662	Synermed Ir 500 Chemistry Analyzer	Synermed, Inc.	JIQ	Class I	1994-04-26
K935515	Multicheck(tm)	Radiometer America, Inc	JJS	Class I	1994-04-26
K935496	Nanosep N10	Intersep, Ltd.	JJH	Class I	1994-04-26
K935425	Metronic Buchbinder Envoy Percutaneous Catheters	Medtronics Interventional Vascular	DQY	Class II	1994-04-26
K935402	Angiographic Balloon Catheter by J-Lloyd	J-Lloyd Medical, Inc.	DQO	Class II	1994-04-26
K935296	Clostridium Difficile Tox-B Test	Techlab, Inc.	LLH	Class I	1994-04-26
K935120	Eml 100	Radiometer America, Inc	JGS	Class II	1994-04-26
K934925	Beckman Ammonia Amm Reagent/ Cx Ammonia Calibrator	Beckman Instruments, Inc.	JIF	Class I	1994-04-26
K934669	Arc	Medelec, Ltd.	BSZ	Class II	1994-04-26
K934650	Cedia Dau Controls	Medical Analysis Systems, Inc.	DIF	Class I	1994-04-26
K934275	Paramax Alcohol Reagent	Baxter Diagnostics, Inc.	DIC	Class II	1994-04-26
K934261	Erbokryo Ca Cryosurgical System	ERBE Elektromedizin GmbH	GEH	Class II	1994-04-26
K934068	Beckman Direct Bilirubin Reagent	Beckman-Diagnostic Systems Group	CIG	Class II	1994-04-26
K934013	Resolve Systems Alkaline Phosphatase Test Kit	Isolab, Inc.	CIN	Class II	1994-04-26
K933969	Tapered Abutment and Related Components	ZimVie US Corp LLC	DZE	Class II	1994-04-26
K933869	Extension Set with 0.22 Micron 96 Hour Filter	Baxter Healthcare Corporation	FPB	Class II	1994-04-26
K932925	Bone Anchor for Soft Tissue Attachment	Vesitec Medical, Inc.	JDR	Class II	1994-04-26