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 2026-10-15, 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 3223 of 3528

510(k) clearances, page 3223 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K821263	Select Bipolar Coagulation Forceps	Zeiss	GEI	Class II	1982-06-10
K821095	Sphygurite	Associated Medical Devices, Inc.	DXQ	Class II	1982-06-10
K821069	Model As6m Infusion Pump	Baxter Healthcare Corporation	FRN	Class II	1982-06-10
K820998	Dentron-Direct-Tray	Dentron, Inc.	EBH	Class I	1982-06-10
K820997	Dentron-Exact - Tray	Dentron, Inc.	EBH	Class I	1982-06-10
K820934	Syphilis Bio-Enzabead Kit	Biometics Laboratory Products	LIP	Class II	1982-06-10
K820755	The Original Leinbach Platform Total Hip	Allo Pro Corp.	KWL	Class II	1982-06-10
K827504	Size Sensing Cassette Tray	Midwest X-Ray Equipment Co.			1982-06-09
K827502	Model Dps-4050 Digital Radiography System	Philips North America LLC			1982-06-09
K827501	Model 580 Digital Radiography System	Technicare Corp.			1982-06-09
K821573	Eosin Y Solution Alcholic	Sigma Chemical Co.	HYB	Class I	1982-06-09
K821546	Monitoring Device Enuresis Alarm & Acc.	Wetbell, Inc.	KPN	Class II	1982-06-09
K821529	Disposable Hypodermic Needles	Medcare Disp Products, Inc.	FMI	Class II	1982-06-09
K821528	Syringe, Piston	Medcare Disp Products, Inc.	FMF	Class II	1982-06-09
K821521	Stabilor Nf	J. Aderer, Inc.	EJT	Class II	1982-06-09
K821515	Vented Nitroglycerin i.v. Set	Abbott Medical	FPA	Class II	1982-06-09
K821510	A Thenium	Williams Gold Refining Co., Inc.	EJS	Class II	1982-06-09
K821508	Rionet Hearing Aid	Rion Acoustic Instruments, Inc.			1982-06-09
K821489	Cordia Tg	Cordis US Corp.	JZO	Class II	1982-06-09
K821486	Micro Drills	Spire Medical, Inc.	GFG	Class I	1982-06-09
K821484	Dawn Low Speed Handpiece System	Young Dental Manufacturing Co 1, LLC.	EFB	Class I	1982-06-09
K821458	Dynamic Funtional Positioner	Dynamic Functional Positioner, Inc.	KMY	Class I	1982-06-09
K821447	Model Beruafon T85 & T95	Beruafon, Inc.	ESD	Class I	1982-06-09
K821446	Degudent 14	J. Aderer, Inc.	EJT	Class II	1982-06-09
K821407	Deva M	J. Aderer, Inc.	EJS	Class II	1982-06-09
K821396	Out-Rite Waste Disposable Bag	Kleen Test Products Corporation	LDQ		1982-06-09
K821390	Custom, in-the-Ear Hearing Aid	Ear-Tronics, Inc.	ESD	Class I	1982-06-07
K821331	Medi-Seal Sterilization Pouches & Tub	Medical Industries Packaging, Inc.	FRG	Class II	1982-06-07
K821330	Gas Sterilization Pouches	Medical Industries Packaging, Inc.	FRG	Class II	1982-06-07
K821325	Oticon	Oticon, Inc.	ESD	Class I	1982-06-07
K821306	Head-Up Supine Safety Support Cushion	Med-Life, Inc.	EPW	Class I	1982-06-07
K821226	Dental Amalgam Alloy	Dental Alloyers Intl., Inc.	EJJ	Class II	1982-06-07
K821221	Dental Impression Material	Crown Delta Corp.	ELW	Class II	1982-06-07
K821217	Reigning Denture	Oki Shiks USA, Ltd.	EBI	Class II	1982-06-07
K827410	Literature on the Sonadent	L&R Mfg. Co., Inc			1982-06-04
K821613	E.g. Bridge Gold	J. Aderer, Inc.	EJT	Class II	1982-06-04
K821570	Pneumo Pulssor III	Strom Corp.	BYI	Class II	1982-06-03
K821566	Orthopedic Fixation Devices	Howmedica Corp.	KTW	Class II	1982-06-03
K821543	Ipa for Detection of Phenobarbital	Electro-Nucleonics Laboratories, Inc.	LFN	Class II	1982-06-03
K821542	Virgo Immuno-Precipitation Assay Tobra	Electro-Nucleonics Laboratories, Inc.	LCR	Class II	1982-06-03
K821503	Iris Urine Stain	Intl. Remote Imaging Systems	ICF	Class I	1982-06-03
K821494	Ria Stat 16	E. R. Squibb & Sons, Inc.	JJJ	Class I	1982-06-03
K821474	Ultrachem Uric Acid Aidh #65047	EMD Millipore Corporation	CDO	Class I	1982-06-03
K821473	Ultrazyme Plus Cki, #64978,65027&65028	EMD Millipore Corporation	CGS	Class II	1982-06-03
K821472	Ultrachem Crea #64972	EMD Millipore Corporation			1982-06-03
K821395	Saddlebag Instrument Pad W/pouches	Kleen Test Products Corporation			1982-06-03
K821394	Suture-Safe 40 Adhesive Needle Counter	Kleen Test Products Corporation	MMK	Class II	1982-06-03
K821354	Conphar Mayo Hegar Needle Holder	Conphar, Inc.	GDF	Class I	1982-06-03
K821343	Bdh Femoral Component	Intermedics Orthopedics	KWL	Class II	1982-06-03
K821341	Ioi Metal Backed Tibial Component	Intermedics Orthopedics	HRY	Class II	1982-06-03