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 2026-10-05, 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 3494 of 3526

510(k) clearances, page 3494 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K770505	Shake-N-Warm	Signal West	IMD	Class I	1977-04-05
K770501	Knee Cuff for Expressing Fluid	Robert R. Moore			1977-04-05
K770500	3 Port Luer	Unimetrics Corp.	EOQ	Class II	1977-04-05
K770468	Unipolar Lead Configuration Conductor	Daig Corp.	DTB	Class III	1977-04-05
K770419	Centurion	Johnson & Johnson Professionals, Inc.	DXY	Class III	1977-04-05
K770387	Unicatch	W.G. Whitney Corp.	FMH	Class I	1977-04-05
K770381	Isolation Kit	American Hospital Supply	LDQ		1977-04-05
K770372	Sterilizer, Steam, Castle 3000	Castle Co.	FLE	Class II	1977-04-05
K770361	Tray, Blood Gas, Cat. No. 4010	Concord Laboratories, Inc.	FMF	Class II	1977-04-05
K770351	Meter, IV Ph, Model Zeromatic	Beckman Instruments, Inc.	JQY	Class I	1977-04-05
K770329	Womb Prep Kit	American Hospital Supply	GEN	Class I	1977-04-05
K770322	Phaldebas Digoxin Ria	Pharmacia, Inc.	LCS	Class II	1977-04-05
K770319	Reagent Cpk, Enzyme	Icn Pharmaceuticals, Inc.	CGS	Class II	1977-04-05
K770318	Reagent Got, Enzyme	Icn Pharmaceuticals, Inc.	CIT	Class II	1977-04-05
K770315	Bun, Enzymatic	Icn Pharmaceuticals, Inc.	CDQ	Class II	1977-04-05
K770313	Reagent Ldh-L, Enzyme	Icn Pharmaceuticals, Inc.	CFJ	Class II	1977-04-05
K770312	Chemistry Control, Abnormal	Icn Pharmaceuticals, Inc.	JJY	Class I	1977-04-05
K770310	Chemistry Control, Normal	Icn Pharmaceuticals, Inc.	JJY	Class I	1977-04-05
K770307	Micro/pettor, Smi	Lederle Laboratories	JQW	Class I	1977-04-05
K770306	Analyzer, 751 Kinetic/endpoint	Sclavo, Inc.	JJQ	Class I	1977-04-05
K770253	Microfiltration Set Mf10	Biotest-Serum-Institut	CAK	Class II	1977-04-05
K770238	Overdose Kit	American Hospital Supply	FMF	Class II	1977-04-05
K770233	Sterile Suction Catheter W/control	Chesire Laboratories	JOL	Class II	1977-04-05
K770201	T3 Ria (Peg) Diagnostic Kit	Abbott Medical	CDP	Class II	1977-04-05
K770179	Cardiac Catheterization Lab Monitor Sys	General Electric Co.	DXG	Class II	1977-04-05
K770057	Ndna Immunopath Fluoro-Kit	Clinical Sciences, Inc.	DHN	Class II	1977-04-05
K770573	Acta-Scanner R 0200Fs	Pfizer Medical Systems, Inc.	JAK	Class II	1977-03-30
K770571	Tray, Anesthesia, Epidural, Continuous	Travenol Laboratories, S.A.	CAZ	Class II	1977-03-30
K770554	Narkomed Anesthesia Machine	Draeger, Inc.	BSZ	Class II	1977-03-30
K770552	Catheter, Kidney Dialysis, Hemo-Cath II	Medical Disposables Intl., Inc.	KOC	Class II	1977-03-30
K770549	Pediatric Anesthesia Circuit	Inspiron Corp.	CAI	Class I	1977-03-30
K770524	Transducer Protector, Rt-901, Rt-902	Renal Systems, Inc.	KOC	Class II	1977-03-30
K770522	Catheter, Gruntzig, Ballon	Cook, Inc.	DYG	Class II	1977-03-30
K770516	Membrane Source-Ex Series Dialyzer Cart.	Extracorporeal Medical Specialities, Inc.	KNX	Class II	1977-03-30
K770512	Cannula, Intravenous, R	Sherwood Medical Industries	DQR	Class II	1977-03-30
K770503	Louisville Clamp Product #65-172	Edward Weck, Inc.	DXC	Class II	1977-03-30
K770478	Adapter, Cordis	Cordis US Corp.	DTD	Class II	1977-03-30
K770477	Citadel Reference Electrode	Sherwood Medical Industries	DRF	Class II	1977-03-30
K770442	Sump Drain, W/filter, Argyle Edlich	Sherwood Medical Industries	GBX	Class I	1977-03-30
K770394	Thrombo-Screen at-111 Kit	Bay Area Hema. Onco. Clinic. & Res. L	JBQ	Class II	1977-03-30
K770374	Stylette, Slick, Cat. No. 2000B	Medical Products Div. P.O.L.A. Plasti	BSR	Class I	1977-03-30
K770317	Glucose Trinder, Enzymatic	Icn Pharmaceuticals, Inc.	CGA	Class II	1977-03-30
K770316	Alkaline Phosphatase Enzymatic	Icn Pharmaceuticals, Inc.	CJE	Class II	1977-03-30
K770314	Reagent Gpt, Enzyme	Icn Pharmaceuticals, Inc.	CKA	Class I	1977-03-30
K770311	Glucose Reagent, Enzymatic	Icn Pharmaceuticals, Inc.	CFR	Class II	1977-03-30
K770300	Colon Irrigation Dev.,colon-a-Sun Coloni	Sun Product Dist., Inc.	FCE	Class I	1977-03-30
K770294	Port-a-Bath	Kathco, Inc.	ILK	Class II	1977-03-30
K770231	Mid-Stream Collection Set	Chesire Laboratories	FMH	Class I	1977-03-30
K770217	Lance Ltd. Steri. Stitch Cutter Blade	Aeroceuticals	GES	Class I	1977-03-30
K770181	i.v. Catheter Placement Unit	American Viggo	FOZ	Class II	1977-03-30