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 2026-10-08, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,902 of the 176,299 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	2,502

176,299 records, page 3455 of 3526

510(k) clearances, page 3455 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K772394	Kalrn Face-Life Scissors	Edward Weck, Inc.	FZI	Class II	1978-03-09
K772383	Long Jewelers Forceps	Edward Weck, Inc.	GEN	Class I	1978-03-09
K772378	Neivs Tracheotomy Retractor	Edward Weck, Inc.	GAD	Class I	1978-03-09
K772376	Neivert Osteotome	Edward Weck, Inc.	KDG	Class I	1978-03-09
K772374	Silver Osteotome	Edward Weck, Inc.	KDG	Class I	1978-03-09
K772373	Anderson-Neivert Osteotome	Edward Weck, Inc.	KDG	Class I	1978-03-09
K772350	Patient Alert Model 555	Intermedics, Inc.	DXH	Class II	1978-03-09
K772282	Hodge Tube	Mallinckrodt Critical Care	FEG	Class II	1978-03-09
K780317	Total Hip System, Harris Hd2	Howmedica Corp.	JDI	Class II	1978-03-06
K780035	Minivisor	Metrix Teknika, Inc.	HEL	Class II	1978-03-06
K780219	Analysis Sys., Emit Man. Thyroxine Assay	Syva Co.	CDX	Class II	1978-03-03
K780218	Analyzer, Emit AED Assays to Centrifiche	Syva Co.	DIP	Class II	1978-03-03
K780208	Aspirator, Manuel	Dade, Baxter Travenol Diagnostics, Inc.	JQW	Class I	1978-03-03
K780204	Chemistry Control & Reference Serums	Hyland Therapeutic Div., Travenol Laboratories	JJT	Class I	1978-03-03
K780148	Ria for Folates & Vit. B12, Combo Kit	Ria Products, Inc.	CGN	Class II	1978-03-03
K780110	Csf Total Protein Test Set #0340	Stanbio Laboratory	JGQ	Class II	1978-03-03
K780096	Ldh Isoenzyme Control Serum	Worthington Biochemical Corp.	JJY	Class I	1978-03-03
K772308	Autozyme Glucose Oxidase (Trinder)	J.T. Baker Chemical Co.	CGA	Class II	1978-03-03
K780292	Tria-Peg Ria Diag. Kit	Nuclear Diagnostics, Inc.	CDP	Class II	1978-03-02
K780281	Immufuge Disp. Liner	Dade, Baxter Travenol Diagnostics, Inc.	KSO	Class I	1978-03-02
K780278	Radiation Therapy Treat. Plan. Sys.	Pfizer Medical Systems, Inc.	JAD	Class II	1978-03-02
K780271	Cobe Stopcock	Cobe Laboratories, Inc.	DTL	Class II	1978-03-02
K780248	Cronex Qc-1 Processor	E.I. Dupont de Nemours & Co., Inc.	IXW	Class II	1978-03-02
K780243	Tampon, Rely Modified	Procter & Gamble Mfg. Co.	HEB	Class II	1978-03-02
K780229	Abdominal Belt	Zimmer GmbH	KTD	Class I	1978-03-02
K780201	Speaker-Amplifier & Recorder Interface	L&M Ultrascope Life Monitoring Sys.	JAF	Class II	1978-03-02
K780200	Ultrascope	L&M Ultrascope Life Monitoring Sys.	JAF	Class II	1978-03-02
K780186	Neuromod Stimulator Model 3723	Medtronic, Inc.	GZJ	Class II	1978-03-02
K780177	Fetal Monitor Model 112	GE Medical Systems Information Technologies, Inc.	HGM	Class II	1978-03-02
K780176	Display System Model 428	GE Medical Systems Information Technologies, Inc.	HGM	Class II	1978-03-02
K780165	Processor, Video Image Vip-550	Ohio Nuclear, Inc.	IYX	Class I	1978-03-02
K780155	Dual Channel Pulse Height Analyzer	Iso Graphics, Inc.	IYX	Class I	1978-03-02
K780126	Dilator, Vessel & Introducer, Sheath	Argon Medical Corp.	DRE	Class II	1978-03-02
K780098	Liquid Oxygen Unit, Portable 73Byj	Andonian Cryogenics, Inc.	BYJ	Class II	1978-03-02
K780047	Platelet Aggregating Reagents	Dade, Baxter Travenol Diagnostics, Inc.	JOZ	Class II	1978-03-02
K772298	Sexual Assault Forencic Evidence Kit	Simpson/Basye, Inc.	KXF	Class I	1978-03-02
K772277	Bladder Retention-Cathetherizationtray	Latex Ind., Inc.	FCM	Class II	1978-03-02
K772117	Heat Exchanger, Disp., Omnitherm	Scimed Life Systems, Inc.	DTR	Class II	1978-03-02
K780309	In-the-Ear Hearing Aid, Model Ce-3	Starkey Laboratories, Inc.	ESD	Class I	1978-02-28
K780301	Caulk Tylok	L.D. Caulk Co.	EMA	Class II	1978-02-28
K780300	Hip Plate Removal Instrument	Richard'S Medical Equip., Inc.	HWB	Class I	1978-02-28
K780298	Electro-Surgical Grounding Pad	Johnson & Johnson Professionals, Inc.	GEI	Class II	1978-02-28
K780291	Ulnar-Radial Approximater	Edward Weck, Inc.	GDJ	Class I	1978-02-28
K780290	Ulnar-Radial Clip	Edward Weck, Inc.	GDJ	Class I	1978-02-28
K780288	Bracheal-Large Vessel Clip	Edward Weck, Inc.	GDJ	Class I	1978-02-28
K780286	Brachial-Large Vessel Approximator	Edward Weck, Inc.	GDJ	Class I	1978-02-28
K780282	Barrier Hip Pack W/ Fabric 450	Surgikos, Inc.			1978-02-28
K780277	Influenza Hi Preserum A/texas	Flow Laboratories, Inc.	GNS	Class I	1978-02-28
K780276	Influenza Hi Antiserum A/texas	Flow Laboratories, Inc.	GNS	Class I	1978-02-28
K780275	Influenza Ha Antigen A/ussr	Flow Laboratories, Inc.	GNT	Class I	1978-02-28