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 3317 of 3528

510(k) clearances, page 3317 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K802167	Percor Datascope Intra-Aortic Balloon	Datascope Corp.	DSP	Class II	1981-01-13
K801601	Datascope/avco Connector	Datascope Corp.	DSP	Class II	1981-01-13
K803298	Mini-Tip Culturette	Marion Laboratories, Inc.	JTW	Class I	1981-01-12
K803252	Micromedic Reagent Dispenser	Micromedic Systems	JTC	Class I	1981-01-12
K803233	Meurometrics Monitor	Dade Medical, Inc.	GWS	Class I	1981-01-12
K802931	Influenza a & B S-Antigen & Controls	Orion Diagnostica, Inc.	GNX	Class I	1981-01-12
K802760	Petal Soft Plastic Applicator Tampax	Tampax, Inc.	HEB	Class II	1981-01-12
K802458	Kevorkian-Younge Biopsy Curette #90-6611	J. Sklar Mfg. Co., Inc.	HFB	Class I	1981-01-12
K802457	Kevorkian-Younge Biopsy Punch, #90-6610	J. Sklar Mfg. Co., Inc.	HFB	Class I	1981-01-12
K802315	Uterine Sound	Gynemetrics, Inc.	HHM	Class I	1981-01-12
K802313	Uterine Curette	Gynemetrics, Inc.	HCY	Class I	1981-01-12
K803284	Osteo Oscilair	Richard'S Medical Equip., Inc.	HSZ	Class I	1981-01-09
K803259	Closed System Urethral Catheteriz. Set	Medical Devices Inc.	KOD	Class II	1981-01-09
K803254	Liquid-Stat Reagent for Assay of Choles.	Beckman Instruments, Inc.	CHH	Class I	1981-01-09
K803240	Corning 760 Fluorometer/densitometer	Transidyne General Corp.	JQT	Class I	1981-01-09
K803239	Softgood Products and Splints	Danek Medical, Inc.	IPX	Class I	1981-01-09
K803237	Ames Sera-Pak Albumin Reagent Kit	Miles Laboratories, Inc.	CIX	Class II	1981-01-09
K803216	Centrifichem Ast/sgot Optimized Reagent	Union Carbide Corp.	CIT	Class II	1981-01-09
K803190	Ethox/barron #2000 Food Pump-Enteral Fed	Ethox Corp.	FRN	Class II	1981-01-09
K803187	Argyle Universal Poole Suction Tube	Sherwood Medical Co.	JOL	Class II	1981-01-09
K803180	1-125 Labeled Triiodothyronine(t3)	Pcl-Ria, Inc.	CDP	Class II	1981-01-09
K803176	Interoom(powered Ophthalmic Table)	Jocevest Interoom, Inc.	HRS	Class II	1981-01-09
K803169	Cardiozyme Plus Ck-Total #65046	Harleco	JHS	Class II	1981-01-09
K803168	Cardio Zyme Plus Ck-Mb #65045	Harleco	JHW	Class II	1981-01-09
K803166	Double Ball Joint	Howmedica Corp.	JEC	Class II	1981-01-09
K803141	Conphar Cast Heels	Conphar, Inc.	LGF	Class I	1981-01-09
K803135	Parallel Chemical Analyzer	American Monitor Corp.	JJE	Class I	1981-01-09
K803108	Helena Hba2 Quik Column Method	Helena Laboratories, Corp.	JPD	Class II	1981-01-09
K803098	Tri-Level Radioassay Control Sera	American Diagnostic Corp.	JJY	Class I	1981-01-09
K803091	Triglycerides (UV)-2 Reagents	Reagents Applications, Inc.	CDT	Class I	1981-01-09
K803051	Flame Photometry Reagents	Laboratory Products, Inc.	JIX	Class II	1981-01-09
K802996	Vector-100 X-Ray Generator	Philips North America LLC	IZO	Class I	1981-01-09
K802953	Digital Fluorographic X-Ray System	General Electric Co.	JAA	Class II	1981-01-09
K802941	Cinescope III Radiographic Generator	Controtec, Inc.	IZO	Class I	1981-01-09
K802930	Cytomegalo Virus & Controls	Orion Diagnostica, Inc.	GQH	Class II	1981-01-09
K802888	Raytheon Medical Imaging	Machlett Laboratories, Inc.	IXL	Class II	1981-01-09
K802826	Paragon Electro. Creatine Kinase Test Ki	Beckman Instruments, Inc.	JHX	Class II	1981-01-09
K802778	Liquid Crystal Therm. 8 Event Monitor	Djinnii Industires, Inc.	KPD	Class II	1981-01-09
K802451	Blf Eiken Kit Deter. of B-Lipopr. Frac.	Syn-Kit, Inc.	JHQ	Class I	1981-01-09
K802391	EMG-Ut 40	American Scientific Corp.	HCC	Class II	1981-01-09
K802390	EMG-Ut 30	American Scientific Corp.	HCC	Class II	1981-01-09
K802220	Vitamin B12 (57Co) Radioimmunoassay	Corning Medical & Scientific	CDD	Class II	1981-01-09
K803212	Bauer & Black Arm Sling W/detach. Pouch	BD Becton Dickinson Vacutainer Systems Preanalytic	ILI	Class I	1981-01-08
K803155	Prophylaxis Cup.	Teledyne Densco	EHK	Class I	1981-01-08
K803148	Conphar Percussion Hammer(taylor)	Conphar, Inc.	GWZ	Class I	1981-01-08
K803147	Conphar Adjustable Cervical Collar	Conphar, Inc.	IQK	Class I	1981-01-08
K803144	Conphar Crutch Pads	Conphar, Inc.	INP	Class I	1981-01-08
K803140	Conphar Crutch Grips	Conphar, Inc.	INP	Class I	1981-01-08
K803139	Conphar Arm Slings	Conphar, Inc.	ILI	Class I	1981-01-08
K803137	Conphar Invalid Ring	Conphar, Inc.	KIC	Class I	1981-01-08