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 2026-10-26, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 2774 of 3530

510(k) clearances, page 2774 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K874276	Cui, Versafil(tm), Ste(tm) Tissue Expander	Cox-Uphuff Intl.	FZW	Class I	1987-12-02
K873983	Captain Power Sunglasses Styles: #1020 #1021	Arcotoys, Inc.	HQY	Class I	1987-12-02
K873913	Color Book Illuminator Stand	Richmond Products, Inc.	HJD	Class I	1987-12-02
K873911	Pseudo Isochromatic Color Blindness Test Book - 15	Richmond Products, Inc.	HIT	Class I	1987-12-02
K873901	Companion Mini Oxygen Saver	Medtronic, Inc.	NFB	Class II	1987-12-02
K873817	Spiro Analyzer St-300	Futuremed Div. of Future Impex Corp.	BZG	Class II	1987-12-02
K873634	Bear Vh-820 Humidifier	Bear Medical Systems, Inc.	BTT	Class II	1987-12-02
K873903	Abbott Pap-Eia	Abbott Medical	JFH	Class II	1987-12-01
K873857	Whiteside Ortholoc Revision Hip Stem Prosthesis	Dow Corning Wright	JDI	Class II	1987-12-01
K874502	Gait-Aid Orthopedic Insole	Gait-Aid, Inc.	IQI	Class I	1987-11-30
K873570	Lifecare Exhalation Valve #06-699	Lifecare Services, Inc.	CBP	Class II	1987-11-30
K873367	Olympus Lus Ultrasonic Lithotripter	Olympus Corp.	FEO	Class II	1987-11-30
K871517	Olympus Pf-25 Ultrathin Angioscope	Olympus Corp.	DQX	Class II	1987-11-30
K874515	Concept Suture Needle	Concept, Inc.	HRX	Class II	1987-11-27
K874262	Lad Model 735 Luminometer	Los Alamos Diagnostics	JJQ	Class I	1987-11-27
K873979	Dynamark 1000	Dynamedics, Inc.	DXN	Class II	1987-11-27
K873782	Reuma Test	Sclavo, Inc.	DHR	Class II	1987-11-27
K873760	Superpulse Ambulase (Xam-Sp) CO2 Surgical Laser	Coherent Medical Group	GEX	Class II	1987-11-27
K873740	Rotascreen Eia	Mercia Diagnostics, Ltd.	LIQ	Class I	1987-11-27
K873438	Usci (R) 8F Large Lumen Soft Tip Guide Catheter	C.R. Bard Inc	DQO	Class II	1987-11-27
K873309	Reflex(tm) Ca-T Clip Applier	Richard-Allan Medical Ind., Inc.	FZP	Class II	1987-11-27
K873288	Closed Foley Catheter System	Todd Medical, Inc.	KNY	Class II	1987-11-27
K872948	Uresil Thora-Flo Thoracentesis Procedure Kit	Uresil, LLC	JOL	Class II	1987-11-27
K864257	Telephone Defibrillator System	Medphone Corp.	LDD	Class II	1987-11-27
K874662	Myco-Fluor Reagent a & B	Scott Laboratories, Inc.	JTS	Class I	1987-11-25
K874476	Easy-Test Total Protein (Tp) Item Number: 19011	Em Diagnostic Systems, Inc.	CEK	Class II	1987-11-25
K874440	Live Oak Allergen Disc	Incstar Corp.	DHB	Class II	1987-11-25
K874406	Ige Enzyme Immunoassay Test Kit No. Mb-1064	Medix Biotech, Inc.	DGC	Class II	1987-11-25
K874379	Cic-Raji Cell Replacement Enzyme Immunoassay	Cytotech, Inc.	CZY	Class II	1987-11-25
K874364	Bausch & Lomb Renu Rewetting & Lubricating Drops	Bausch & Lomb Incorporated	LPN	Class II	1987-11-25
K874311	Multichem (R) Total Bilirubin	Simmler Inc	CIG	Class II	1987-11-25
K874261	Iq/qca Total Bilirubin	BD Becton Dickinson Vacutainer Systems Preanalytic	CIG	Class II	1987-11-25
K874031	Irma-Count Ferritin W/mono. Antibodies Rkfe1,2,5	Siemens Healthcare Diagnostics Inc.	DBF	Class II	1987-11-25
K873940	Creat Brand O-Rise General Aspirator	Aesthetech Corp.	BTA	Class II	1987-11-25
K873891	Tissue Culture Dishes	Nunc, Inc.	KIZ	Class I	1987-11-25
K873890	Tissue Culture Flasks	Nunc, Inc.	KJA	Class I	1987-11-25
K873889	Tissue Culture Tubes	Nunc, Inc.	KJA	Class I	1987-11-25
K873734	Sysmex F-800 15 Parameter, Semi-Auto Hema Analyzer	Toa Medical Electronics USA, Inc.	GKZ	Class II	1987-11-25
K873708	Fiax Test Kit for Ena (Rnp/sm) Antibodies	Whittaker Bioproducts, Inc.	LLL	Class II	1987-11-25
K873593	Biosure Specimen Collection Container	Biosure, Inc.	KDT	Class I	1987-11-25
K873552	Cannula and General Purpose Aspirator	Cosmedtech, Inc.	HHI	Class II	1987-11-25
K873387	Video Arthroscope, 1.7Mm X 55 Mm	Arthropedics, Inc.	HXR	Class I	1987-11-25
K873080	Arthrobot 101 Upper Limb Traction Accessory	Andronic Devices, Ltd.	JEA	Class I	1987-11-25
K873079	Arthrobot 100 Upper Limb Positioner	Andronic Devices, Ltd.	JEA	Class I	1987-11-25
K870584	O.p.t.(tm) Ovulation Prediction Test	Warner-Lambert Co.	CEP	Class I	1987-11-25
K874593	Ace Selftapping Cancellous Bone Screw	Ace Medical	HWC	Class II	1987-11-24
K874578	Emit Convenience Pack: Theophylline Assay	Syva Co.	KLS	Class II	1987-11-24
K874456	Chlamydia Stat Direct Smear Collection Kit	Tm & M C/O Burditt,Bowles,Radzius & Ruberry, Ltd.	LIO	Class I	1987-11-24
K874397	Easy-Test Hdl Cholesterol Item Number 16683	Em Diagnostic Systems, Inc.	LBS	Class I	1987-11-24
K874295	Esophageal Stethoscope W/electrical Conductors	Sheridan Catheter Corp.	BZT	Class II	1987-11-24