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 2026-10-22, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 2875 of 3529

510(k) clearances, page 2875 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K861894	Agar 9K TENS	Solcoor, Inc.	GZJ	Class II	1986-09-09
K861325	Maxi-Use O2 Device	B & F Medical Products, Inc.	NFB	Class II	1986-09-09
K863209	US Plus-Pak(r) Surgical System	Ipax, Inc.	HQC	Class II	1986-09-08
K863006	125-I Tsh Receptor Antibody Kit	Cronus	JZO	Class II	1986-09-08
K862778	Hall Cannlula System	Hall Surgical, Division of Zimmer, Inc.	HRX	Class II	1986-09-08
K862762	Tina-Quant(r) Igm	Boehringer Mannheim Corp.	DFT	Class II	1986-09-08
K862593	Das 211	Philips North America LLC			1986-09-08
K862235	Ciba Corning Magic Lite Analyzer	Ciba Corning Diagnostics Corp.	JJE	Class I	1986-09-08
K862189	Organon Teknika Toxonostika Igg Microelisa System	bioMerieux, Inc.	LGD	Class II	1986-09-08
K861983	Sutter Lesser Metatarsal Cap	Sutter Biomedical, Inc.	KWD	Class II	1986-09-08
K860830	Technicon H.1 System, T Lymphocytes Method	Technicon Instruments Corp.	LIZ	Class II	1986-09-08
K863324	Triad Impact	Dentsply Intl.	EBI	Class II	1986-09-05
K863303	Model 617D	Quinton, Inc.	LDD	Class II	1986-09-05
K863161	Table, Operating Room, Hydraulic	Kamiya Tsusan Kaisha, Ltd.	FWW	Class I	1986-09-05
K863150	Bowen Cannula	Bowen & Company, Inc.	GEA	Class I	1986-09-05
K863149	Bowen Probe	Bowen & Company, Inc.	HXB	Class I	1986-09-05
K863148	Bowen Knot Passer	Bowen & Company, Inc.	HXI	Class I	1986-09-05
K863147	Glenoid Drill	Bowen & Company, Inc.	HTW	Class I	1986-09-05
K863146	Bowen Suture Passer	Bowen & Company, Inc.	HXI	Class I	1986-09-05
K863047	Flexicair	Ssi Medical Services, Inc.	IOQ	Class II	1986-09-05
K862942	Photo Clearfil Bright	Kuraray Co.	EBF	Class II	1986-09-05
K862532	Dumbach Titanium Mesh Implant System	Biomet Microfixation	JEY	Class II	1986-09-05
K860353	Syringe Infusion Pump	Travenol Laboratories, S.A.	FRN	Class II	1986-09-05
K860237	Omf-7101 Fetal Monitor	Nihon Kohden America Inc	HGM	Class II	1986-09-05
K863291	Il Cellect 8	Instrumentation Laboratory Co.	GKL	Class II	1986-09-04
K863290	Il Cellect 7	Instrumentation Laboratory Co.	GKL	Class II	1986-09-04
K863104	Total Hemoglobin	J. D. Assoc.	KHG	Class II	1986-09-04
K863085	Coulter Counter Model T-540	Coulter Electronics, Inc.	GKL	Class II	1986-09-04
K863084	Coulter Counter Model T-890	Coulter Electronics, Inc.	GKL	Class II	1986-09-04
K862974	Alternate Package Config. for Implant. Pulse Gen.	Medtronic, Inc.	DXY	Class III	1986-09-04
K862825	Hi-Lo Elevator Flat Table	Garrels X-Ray Products, Inc.	IXQ	Class II	1986-09-04
K862774	Asserachrom Pf4 Kit	American Bioproducts Co.	LCO	Class II	1986-09-04
K862763	Tina-Quant(r) Iga	Boehringer Mannheim Corp.	CZP	Class II	1986-09-04
K862665	Novacyte-U	Xsirius Medical, Inc.	KDT	Class I	1986-09-04
K862649	Cytotech Cic Enzyme Immunoassay	Cytotech, Inc.	DAK	Class II	1986-09-04
K862609	Interface Arterial Blood Filter, Model 44	Medical, Inc.	DTM	Class II	1986-09-04
K862591	Interface Arterial Blood Filter, Model 42	Medical, Inc.	DTM	Class II	1986-09-04
K862567	Acs Wire Shaper	Advanced Cardiovascular Systems, Inc.	DQX	Class II	1986-09-04
K862374	Cellect 8E Automated Blood Cell Counters	Instrumentation Laboratory Co.	GKL	Class II	1986-09-04
K862327	Model Rcv Reflux Check Valve	Life-Tech Intl., Inc.	FAP	Class II	1986-09-04
K862251	Modified Bio-Flow Model 200 Urine Flow Device	Bio-Flow, Inc.	KNX	Class II	1986-09-04
K862150	Model 8-B with Os-1 Attachment (C02 Laser for ENT)	Directed Energy, Inc.	EWG	Class II	1986-09-04
K861973	D-Di Test Kit	American Bioproducts Co.	GHH	Class II	1986-09-04
K854653	Cilco Sonometrics Digicon	CooperVision, Inc.	IYO	Class II	1986-09-04
K863289	Cdc Anaerobic Agar W/sheep Blood, Kana-&Vancomycin	Gibco Laboratories Life Technologies, Inc.	JSJ	Class I	1986-09-03
K863248	Pb Graphics Printer and Pb Video Display	Datex Division Instrumentarium Corp.	CBQ	Class II	1986-09-03
K863204	Deka Jr.	Deka Research & Development Corp.	LDR	Class II	1986-09-03
K863200	Computon(r)	Optical Radiation Corp.	HKX	Class II	1986-09-03
K863182	Eye Barrier	O.R. Concepts, Inc.	HQZ	Class I	1986-09-03
K863125	Eve Collection (Eyeglass Frame)	Precision Lens Crafters	HQZ	Class I	1986-09-03