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 2026-10-12, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,969 of the 176,366 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	2,569

176,366 records, page 3264 of 3528

510(k) clearances, page 3264 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K812874	Pediatric Microaggregate Blood Filter	Abbott Medical	CAK	Class II	1981-11-02
K812867	Steri-Vac #400C Gas Sterilizer	3M Company	FLF	Class II	1981-11-02
K812852	Set for Aseptic Decanting of a Flex i.v	Dip, Inc.	KPE	Class II	1981-11-02
K812761	Flow-Directed Balloon Thermodilution	Nova Medical Specialties	KRG	Class III	1981-11-02
K812757	Sorenson Thermodilution Cardiac Comput	Sorensen Research	DXG	Class II	1981-11-02
K812745	Warming Listhts #96H & 96Ht	J. H. Emerson Co.	FMT	Class II	1981-11-02
K812742	Shiley Arterial Filter W/40 Micron Scree	Shiley, Inc.	DTM	Class II	1981-11-02
K812711	Sterile Gauze Pads 12Ply	Medspec Corp.	NAB	Class I	1981-11-02
K812710	Sterile Laparotomy Sponges-X-Ray Detect	Medspec Corp.	GDY	Class I	1981-11-02
K812707	Sterile Dissector Sponges-X-Ray Detect	Medspec Corp.	GDY	Class I	1981-11-02
K812623	Cleaning Solution for Radiometer Osm2	Fisher Scientific Company L.L.C.	CHL	Class II	1981-11-02
K812572	Gauze Sponges	Worldwide Surgical Gauze	EFQ	Unclassified	1981-11-02
K812556	Dade Immu-Trace Tri-Rac R Tri-Level R.c	American Dade	JJY	Class I	1981-11-02
K812440	Power Pack	Black & Decker(Tm)			1981-11-02
K812439	Dual Mpc Charger	Black & Decker(Tm)			1981-11-02
K812438	Sagittal Saw	Black & Decker(Tm)	GEY	Class I	1981-11-02
K812437	150 Driver Reamer	Black & Decker(Tm)	GEY	Class I	1981-11-02
K812436	450/800 Drill	Black & Decker(Tm)	HBC	Class II	1981-11-02
K812409	Sphygmomanometer	Somatronix Research Corp.	DXN	Class II	1981-11-02
K812263	Kenz-Gelect	Suzuken Co., Ltd.	GYB	Class II	1981-11-02
K811752	Fe-Cult Plus	Gamma Biologicals, Inc.	KHE	Class II	1981-11-02
K812870	Improved Playtex Tampon	Playtex, Inc.	HEB	Class II	1981-10-29
K812847	Xylene	Richard-Allan Medical Ind., Inc.	KEM	Class I	1981-10-29
K812846	Clear-Rite II	Richard-Allan Medical Ind., Inc.	KEM	Class I	1981-10-29
K812816	Model 841 Endocardial Tined Lead	Pacesetter Systems	DTB	Class III	1981-10-29
K812815	Model 833 Endocardial Tined Lead	Pacesetter Systems	DTB	Class III	1981-10-29
K812790	Implantable Ventricular-Inhibited Cardi	Telectronics, Inc.	DXY	Class III	1981-10-29
K812781	Temporary Pervenous J-Atrial Lead	Cordis US Corp.	LDF	Class II	1981-10-29
K812756	Adaptaid #365-38	Intermedics, Inc.	DTD	Class II	1981-10-29
K812663	Solarium Combination	Tech-Pro, Inc.	FTC	Class II	1981-10-29
K812358	Model 325T Programmable Pulse Generator	Cook Pacemaker Corp.	DXY	Class III	1981-10-29
K812321	Hydroxi-Flex Implant	Impladent, Ltd.	DZE	Class II	1981-10-29
K812228	Moxalactam 30 Mcg. Sensitivity Discs	Difco Laboratories, Inc.	JTN	Class II	1981-10-28
K812002	Eluaid	Ortho Diagnostic Systems, Inc.	GGK	Class I	1981-10-28
K812892	S/p Serum Dropper Pipets	American Dade	KSS	Class I	1981-10-27
K812824	Pressure Disc Component for Accuset	Imed Corp.	FRN	Class II	1981-10-27
K812823	Imed Model 970 & 975 Vol. Infusion Pump	Imed Corp.	FRN	Class II	1981-10-27
K812813	Intermedics Programmer, Model 522-03	Intermedics, Inc.	KRG	Class III	1981-10-27
K812812	Intermedics Adaptaid Step-Down Adapter	Intermedics, Inc.	DTD	Class II	1981-10-27
K812882	Rheumatex	Armkel, LLC	DHR	Class II	1981-10-26
K812881	Immunex Crp	Armkel, LLC	DCN	Class II	1981-10-26
K812877	Penase	Analytab Products, Inc.	JTO	Class I	1981-10-26
K812872	Optional Total Ca-Module for Il 504/508	Instrumentation Laboratory Co.	CIS	Class II	1981-10-26
K812862	Api Germ Tube	Analytab Products, Inc.	JTO	Class I	1981-10-26
K812860	Immunoassay Plate	Skatron, Inc.	JTC	Class I	1981-10-26
K812859	Ids Porphyrin Reagent	Innovative Diagnostic Systems, Inc.	JTO	Class I	1981-10-26
K812825	Flo-Cor I	Biotrine Corp.	JAX	Class II	1981-10-26
K812821	H-103 Igg, H-104 Iga, H-105 Igm	Immulok, Inc.	DFZ	Class II	1981-10-26
K812779	Extensions-Lusatztisch	The Telos Co.	HST	Class I	1981-10-26
K812746	Thoracic Drainage Set #55-Db2-G	J. H. Emerson Co.	KDQ	Class II	1981-10-26