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 3488 of 3526

510(k) clearances, page 3488 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K770939	Urine Tester, Model 701	Brother Scientific Products, Inc.	EXR	Class II	1977-06-03
K770932	Geramco Low Temp Glaze	Johnson & Johnson Professionals, Inc.	EIH	Class II	1977-06-03
K770931	Applic System Applier, Espe	Espe GmbH (US)	EID	Class I	1977-06-03
K770897	Urodynamic Instruments	Life-Tech Instruments, Inc.	EXY	Class II	1977-06-03
K770896	Colposcope Model II	Dynatech Cryomedical Co.	HEX	Class II	1977-06-03
K770888	Pomerantzeff Equator Plus Camera	Medical Instrument Research Assoc., Inc.	HKI	Class II	1977-06-03
K770876	Improved Transgrow	Granite Diagnostics, Inc.	JTY	Class II	1977-06-03
K770875	Improved Thayer Martin (Jembec)	Granite Diagnostics, Inc.	JTY	Class II	1977-06-03
K770866	Rabbit Complement	Cedarlake Labs, Ltd.	DHL	Class I	1977-06-03
K770832	Portascope II	Mennen Greatbatch Electonics	DPS	Class II	1977-06-03
K770707	Tygon Pac-Monitoring Lines & Fluid Admin	Norton Performance Plastics Corp.	FMG	Class II	1977-06-03
K770701	Hematrak Model 125	Geometric Data, Div. Smithkline Corp.	GKZ	Class II	1977-06-03
K770564	Uric Acid Test Kit	Mallinckrodt Critical Care	CDH	Class I	1977-06-03
K770555	Cpk Isoenzyme Control	Bio-Reagents & Diagnostics, Inc.	JJT	Class I	1977-06-03
K770520	Radioimmunoassay, Quantitipe 125-I-T3	Kallestad Laboratories, Inc.	CDP	Class II	1977-06-03
K770519	Reagent System 153-UV	Sigma Chemical Co.	JKG	Class I	1977-06-03
K770423	Urine Tester, Model No. 707	Brother Scientific Products, Inc.	EXR	Class II	1977-06-03
K770998	Cholesterol Reagent Set	The Dow Chemical Co.	CHH	Class I	1977-06-02
K770949	Computer ECG Tele. Transmission Terminal	The Okun Co.	DXH	Class II	1977-06-02
K770941	Applic System Activator, Espe	Espe GmbH (US)	EID	Class I	1977-06-02
K770929	Bandages, Spec. X-Tra Hard or Plaster	Johnson & Johnson Professionals, Inc.	ITG	Class I	1977-06-02
K770921	Sphygmomanometer, Electronic	Bristoline, Inc.	DXN	Class II	1977-06-02
K770869	Atypical Lymphocyte & Ncb Classification	Geometric Data, Div. Smithkline Corp.	GKZ	Class II	1977-06-02
K770771	Aerosol Effusion System #1740	Hudson Oxygen Therapy Sales Co.	BYH	Class I	1977-06-02
K770736	Monitor, Patient, Model Pm-20N	Cavitron Corp.	CHL	Class II	1977-06-02
K770705	Cardiac Acquisition System, Icr 2001	Instruments for Cardiac Research	DQK	Class II	1977-06-02
K770649	Vac-Rite	Medical Development Co.	KDQ	Class II	1977-06-02
K770470	Worthington Bun	Worthington Biochemical Corp.	CDW	Class II	1977-06-02
K770465	Ria-120 and Estriol Reagent System	BD Becton Dickinson Vacutainer Systems Preanalytic	CGI	Class I	1977-06-02
K770460	Centrifi Chem Calcium Reagent	Union Carbide Corp.	CIC	Class II	1977-06-02
K770406	Technicon Sma & Aaii Systems	Boehringer Laboratories, LLC	CJE	Class II	1977-06-02
K770923	Espetemp (Temp. Cement)	Espe GmbH (US)	EMA	Class II	1977-06-01
K770922	Dental Restorative in Capsules	Espe GmbH (US)	EBF	Class II	1977-06-01
K770913	Urological Biopsy Brush Set	Cook, Inc.	FDX	Class II	1977-06-01
K770906	Anoscope, Optic, Fiber	Welch Allyn Inc	FER	Class II	1977-06-01
K770878	Signal Processor/averager Model 7S11	Medical Systems Corp.	GWJ	Class II	1977-06-01
K770872	Impression Material, Alginate	Espe GmbH (US)	ELN	Class I	1977-06-01
K770748	Test, Ferrozine Iron & Iron Binding	Hycel, Inc.	JMO	Class I	1977-06-01
K770747	Reagent Set, Cholesterol, Cat No. 4024	American Monitor Corp.	CHH	Class I	1977-06-01
K770928	Part No. 66-00121	Harlake Cyprane	BZG	Class II	1977-05-26
K770927	Part No. 66-00311	Harlake Cyprane	BZG	Class II	1977-05-26
K770904	Probe, Blood Flow Detector Plug-in	Medsonics	KNG	Class II	1977-05-26
K770891	Splinh, Forearm	Mizuho Orthopedic Systems Inc	IQM	Class I	1977-05-26
K770890	Splint, Cockup	Mizuho Orthopedic Systems Inc	IQM	Class I	1977-05-26
K770855	Synerview Model 6478	Philips North America LLC	JAK	Class II	1977-05-26
K770854	Luteinizing Hormone Ria Reagent, Lh-Ria	Nichols Institute Diagnostics	CEP	Class I	1977-05-26
K770845	T3 Uptake Reagent Set	The Dow Chemical Co.	KHQ	Class II	1977-05-26
K770837	Screen, Fine, Lanes, Kodak	Eastman Kodak Company	EAM	Class I	1977-05-26
K770836	Ultimat L4 X L4, Liebel-Flarsheim	Mallinckrodt Group, Inc.	KPX	Class II	1977-05-26
K770751	Catheters, Over-the-Needle	Cutter Laboratories, Inc.	FOZ	Class II	1977-05-26