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 2156 of 3531

510(k) clearances, page 2156 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K941718	3M Fluid Control System 8300 Cassette Load	3M Medical Products Group	HRX	Class II	1994-10-07
K941388	3M Fluid Irrigation System	3M Healthcare	HRX	Class II	1994-10-07
K935630	Norta	Beiersdorf, Inc.	EZL	Class II	1994-10-07
K934707	Galileo Arthroscopes	Galileo Electro-Optics Corp.	HRX	Class II	1994-10-07
K934366	Mitek Cancellous Fixation Screw, Cortical Fixation Screw, Soft Tissue Washer	Mitek Surgical Products, Inc.	HWC	Class II	1994-10-07
K931960	Nuffield Total Knee	Turnkey Intergration USA, Inc.	JWH	Class II	1994-10-07
K931753	Corin Thompson Prosthesis, Modification	Corin Orthopedic Products	KWL	Class II	1994-10-07
K931752	Corin Austin-Moore Prosthesis, Modification	Corin Orthopedic Products	KWL	Class II	1994-10-07
K931562	Guardian Surgeon's Gowns	Atkins Healthcare Services	FYA	Class II	1994-10-07
K926374	Silicone Catheter Repair Kits	Akcess Medical Products, Inc.	KOC	Class II	1994-10-07
K923960	Upper Extermity Drape Kit	Medikmark, Inc.	KKX	Class II	1994-10-07
K942551	Therapeutic Drug Monitoring Control, Assayed	Medi-Tech, Inc.	DIF	Class I	1994-10-06
K942501	Ace Cedia Phenobarbital Assay	Schiapparelli Biosystems, Inc.	DLZ	Class II	1994-10-06
K942467	Protectaide Aviator CPR Protection Pack No. 31000	Protectaide, Inc.	CBP	Class II	1994-10-06
K942466	Protectaide CPR Protection Pack No. 17701	Protectaide, Inc.	CBP	Class II	1994-10-06
K941617	Apr Acetabular Insert	Intermedics Orthopedics	JDI	Class II	1994-10-06
K941417	Vitaflon Plus/vasculon	Hogan & Hartson	FOZ	Class II	1994-10-06
K941165	Comet Capnograph Module	Spacelabs, Inc.	CCK	Class II	1994-10-06
K935452	P.f.c. 2 Total Hip System Porous Coated Modular Femoral Component	Johnson & Johnson Orthopaedics, Inc.	LZO	Class II	1994-10-06
K944536	Gsi Knotmaker	General Surgical Innovations	GCJ	Class II	1994-10-05
K944177	Breast Shell	O'Donnell, Byrne & Williams	HFS	Class I	1994-10-05
K944117	Avent Nipple Shield	Avent America, Inc.	HFS	Class I	1994-10-05
K943334	Hawley Retainer Orthodontic Applicance Kit	Jay H. Geller	DZC	Class I	1994-10-05
K942946	Osteograf/d-100 Hydroxylapatite	Ceramed Corp.	LYC	Class II	1994-10-05
K942406	Option Shell	Intermedics Orthopedics	JDI	Class II	1994-10-05
K941506	Ureteral Illuminator	CooperSurgical, Inc.	FCS	Class II	1994-10-05
K940785	Mouth Props	Worldwide Dental, Inc.	EIF	Class I	1994-10-05
K940235	Ortholoc Advantim Ps Lsi Tibial Insert	Wrightmedicaltechnologyinc	JWH	Class II	1994-10-05
K931914	Suture Non-Absorbable Synthetic Polylmide	Surgimetrics International, Ltd.	GAR	Class II	1994-10-05
K944667	Life Pulse Tesuscitation Timer	Green Field Medical Sourcing, Inc.	PMK	Class I	1994-10-04
K944643	Autoneb Accessory Cross (Aac)	Vortran Medical Technology 1, Inc	CAF	Class II	1994-10-04
K944608	Hp M1722a/b and M1723a/b Codemaster	Hewlett-Packard Co.	DQA	Class II	1994-10-04
K944554	Brain Heart Infusion Agar	Carr-Scarborough Microbiologicals, Inc.	JSO	Class II	1994-10-04
K944295	Karl Storz Laryngoscope Accessories	Karl Storz Endoscopy-America, Inc.	CAI	Class I	1994-10-04
K943925	Sweat Controls for Cystic Fibrosis Testing	Quantimetrix Corp.	JJR	Class I	1994-10-04
K943781	Acryderm Advanced Wound Dressing	Acrymed, Inc.	KMF	Class I	1994-10-04
K943684	Hichem Enzyme Verifier Kit	Hi Chem, Inc.	JJT	Class I	1994-10-04
K943529	Patient Trolley 540	Merivaara Instrumentarium Corp.	FPO	Class II	1994-10-04
K943528	Patient Trolley 545	Merivaara Instrumentarium Corp.	FPO	Class II	1994-10-04
K943348	Kls Chin Plate System	Patton, Boggs & Blow	JEY	Class II	1994-10-04
K943347	Kls Mini Osteosynthesis System	Patton, Boggs & Blow	JEY	Class II	1994-10-04
K943346	Manual Surgical Inst. and Acc. to Kls Mini Osteosynthesis System	Patton, Boggs & Blow	JEY	Class II	1994-10-04
K943345	Manual Surgical Inst. and Acc. to Kls Chin Plate System	Patton, Boggs & Blow	JEY	Class II	1994-10-04
K943054	Osteonics Secure-Fit Ad Acetabular Component System	Osteonics Corp.	LPH	Class II	1994-10-04
K943035	P.a.t. System	Mathews Assoc., Inc.	ILQ	Class II	1994-10-04
K942853	Kova Liqua-Trol	Hycor Biomedical	JJW	Class I	1994-10-04
K942364	Hitachi 914 Analyzer	Boehringer Mannheim Corp.	JJE	Class I	1994-10-04
K942330	Apr II Femoral Component (Various)	Intermedics Orthopedics	LZO	Class II	1994-10-04
K942048	Roche Ammonia (Various)	Roche Diagnostic Systems, Inc.	DKB	Class II	1994-10-04
K942046	Pharmacia Deltec Extension Set with Anti-Siphon Valve	Pharmacia Deltec, Inc.	FPA	Class II	1994-10-04