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 2008 of 3531

510(k) clearances, page 2008 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K955483	Trach Mask Model (245, 246)	Hospitak, Inc.	BYF	Class I	1996-02-28
K954840	Alkaline Phosphatase (Alp) Procedure No. 245	Sigma Diagnostics, Inc.	CJE	Class II	1996-02-28
K954411	Galva-5-M	Zimmer Elektromedizin GmbH	IPF	Class II	1996-02-28
K951739	Pump/blood Chemistry Monitor	Via Medical Corp.	LZF	Class II	1996-02-28
K942530	Art-Assist Model Aa-1000	Aci Medical, LLC	JOW	Class II	1996-02-28
K960455	Bipolar Suction Coagulator	Kirwan Surgical Products, LLC	GEI	Class II	1996-02-27
K960228	Expandacell Injecto-Pak Nasal Pack	Summit Medical, LLC	EMX	Class I	1996-02-27
K960207	CPR Laceration Tray	Custom Pack Reliability	FRG	Class II	1996-02-27
K960204	G.e. Sterile, Percutaneous Cholangiographic Tray	GE Healthcare	FRG	Class II	1996-02-27
K960146	G.e. Sterile Disposable Radiographic Contrast Tray	GE Healthcare	IZG	Class II	1996-02-27
K955879	Widex Model Senso Digital (C16)	Widex Hearing Aid Co., Inc.	ESD	Class I	1996-02-27
K955747	Ussc Nonabsorbable Sutures	United States Surgical, A Division of Tyco Healthc	GAT	Class II	1996-02-27
K955723	Stainless Steel Sutures, Flexon Steel Sutures (Stainless)	Davis & Geck, Inc.	GAQ	Class II	1996-02-27
K955632	Orthoplug Soft Bone Design	Sunmed, Inc.	LZN	Class II	1996-02-27
K955631	Orthoplug Hard Bone Design	Sunmed, Inc.	LZN	Class II	1996-02-27
K955626	Medrad/hitachi Breast Imaging Surface Coil	Medrad, Inc.	MOS	Class II	1996-02-27
K955621	Sharplan Lasers, Inc Silktouch 2 Flash Scanner	Sharplan Lasers, Inc.	GEX	Class II	1996-02-27
K954914	Breathe Right Nasal Strip	Cns, Inc.	LWF	Class I	1996-02-27
K954808	Ussc Polyproplene Suture	United States Surgical, A Division of Tyco Healthc	GAW	Class II	1996-02-27
K954719	Intermedics Model 430-07 Bipolar Implantable Endocardial Pacing Lead	Intermedics, Inc.	DTB	Class III	1996-02-27
K954071	Idxview	Idx Systems Corp.	LMD	Class I	1996-02-27
K953616	Preview Surgery Planning Software	Medical Media Systems	LLZ	Class II	1996-02-27
K953257	Oralsensor	Cycura Corp.	HCC	Class II	1996-02-27
K952326	Pulmomist	Global Medical Ent., Inc.	CAF	Class II	1996-02-27
K936111	Chemmate Special Stain Lca-Cd45	Biotek Solutions, Inc.	DEH	Class II	1996-02-27
K960477	Ventilation Tubes	Smith & Nephew, Inc.	ETD	Class II	1996-02-26
K960464	C & B Metabond (Modification)	Parkell, Inc.	EMA	Class II	1996-02-26
K960403	Diamond (Code Name Pt-054)	J.F. Jelenko & Co., Inc.	EJT	Class II	1996-02-26
K955511	Arthopor I & II Acetabular Cup/arthopor II Oblong Acetabular Cup	Joint Medical Products Corp.	LPH	Class II	1996-02-26
K955508	Rosch -Thurmond Fallopian Tube Catheterization Set	Cook Incorporated	LKF	Class II	1996-02-26
K954874	Spectef Protocol	GE Healthcare	KPS	Class II	1996-02-26
K954208	Optetrak Constrained Condylar Knee for Cemented Use Only	Exactech, Inc.	JWH	Class II	1996-02-26
K953825	Angioflush II Fluid Management System	Boston Scientific Corporation	FPA	Class II	1996-02-26
K953508	Compute-Rx Plan Pc3d	Medicalibration Physics Consultant Services, Inc.	IYE	Class II	1996-02-26
K950837	Aurora Imaging System	Advanced Mammography Systems, Inc.	LNH	Class II	1996-02-26
K940331	Keratin Primary Antibody	Ventana Medical Systems Inc	DEH	Class II	1996-02-26
K955910	Dried Gram-Negative Mic/combo Panels	Dade Microscan, Inc.	JWY	Class II	1996-02-23
K955669	Remel Cefepime 30 Ug Susceptibility Disk	Remel Inc	JTN	Class II	1996-02-23
K955496	Uric Acid Cataloge# 220-93/94/97	Sekisui Diagnostics P.E.I. Inc.	KNK	Class I	1996-02-23
K955485	Brun Selective and Flush Angiographic Catheters	B.Braun Medical, Inc.	DQO	Class II	1996-02-23
K955468	Opus Prolactin Controls	Behring Diagnostics, Inc.	JJX	Class I	1996-02-23
K955448	Emit II Lsd Assay, Emit Lsd Calibrators & Emit Lsd Controls	Behring Diagnostics, Inc.	DLB	Class II	1996-02-23
K955375	Easystat Sodium/potassium Analyzer	Medica Corp.	JGS	Class II	1996-02-23
K955374	Easystat Sodium/potassium/chloride Analyzer	Medica Corp.	JGS	Class II	1996-02-23
K955114	Dsl Aactive Dhea Eia Kit	Diagnostic Systems Laboratories, Inc.	JKC	Class I	1996-02-23
K954512	Restore Self Tapping Dental Implant System	Lifecore Biomedical LLC	DZE	Class II	1996-02-23
K954191	Seraquest Cmv Igg	Quest Intl., Inc.	LFZ	Class II	1996-02-23
K953133	Scimed Dispatch Coronary Infusion Catheter	Scimed Life Systems, Inc.	KRA	Class II	1996-02-23
K953118	Caracell	Medtronic, Inc.	CAC	Class II	1996-02-23
K950671	Immulite Toxoplasma Gondii Igg	Siemens Healthcare Diagnostics Inc.	LGD	Class II	1996-02-23