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 2026-10-05, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,902 of the 176,299 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	2,502

176,299 records, page 3516 of 3526

510(k) clearances, page 3516 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K760345	Test, Lactate Dehydrogenase	Princeton Biomedix	CFJ	Class II	1976-10-27
K760333	Jar, Collector for Suction Systems	Harris-Lake, Inc.	GCX	Class II	1976-10-27
K760787	Liberator/stroller	Burditt & Calkins-Siemens-Elema	BYJ	Class II	1976-10-22
K760822	Model Tx-8 Panendoscope	American Cystocope Makers, Inc.	FAK	Class II	1976-10-21
K760821	Reagent System	Sigma Chemical Co.	CJT	Class I	1976-10-21
K760806	Referee Aqueous Triglyceride Stnd	Analytical Products, Inc.	JIS	Class II	1976-10-21
K760805	Ultrasonic Dental Prophylaxis Device	Cavitron Corp.	ELC	Class II	1976-10-21
K760723	Safe-T-Pins Retentive Pin System	Parkell, Inc.	EBL	Class I	1976-10-21
K760717	Flexible Biopsy Forceps	V. Mueller O.V. Baxter Healthcare Corp.	KOA	Class I	1976-10-21
K760715	Flexible Cutting Scissors	V. Mueller O.V. Baxter Healthcare Corp.	KOA	Class I	1976-10-21
K760709	Emit Digokin Assay	Syva Co.	DOG	Class II	1976-10-21
K760703	Sponge and Gauze Forcep Part #S-417-9	Acme United Corp.	GEN	Class I	1976-10-21
K760681	Indirect Fluorescent (Ifa-Ana)	Wampole Laboratories	DHN	Class II	1976-10-21
K760665	Fistula Needle (#11-265)	Cobe Laboratories, Inc.	KOC	Class II	1976-10-21
K760046	Case, Contact Lens, Plastic	Tomlin B. Horsley, Jr.	HPX	Unclassified	1976-10-21
K760842	Geomedic Anametric Total Knee	Howmedica Corp.	HRY	Class II	1976-10-20
K760820	Nalgene Emergency Eye Wash	Nagle Co.	KYG	Class I	1976-10-20
K760817	Orthopedic Tubular Stockinette	Parke-Davis Co.	ILG	Class I	1976-10-20
K760803	Physiological Monitor (Model 870)	Datascope Corp.	DRT	Class II	1976-10-20
K760796	Oraluminator III - Light Source for F.o.	Midwest	EAY	Class I	1976-10-20
K760795	Fiber Optics Dental Hose W/integral L.c.	Midwest	EAY	Class I	1976-10-20
K760794	Fiber Optics High Speed Handpiece	Midwest	EFB	Class I	1976-10-20
K760763	Colposcope (Dynatech Colposcope-Model I	Dynatech Cryomedical Co.	HEX	Class II	1976-10-20
K760753	Cutter Jel-Alginate Impression Mat.	Cutter Laboratories, Inc.	ELW	Class II	1976-10-20
K760544	Catheter, Peritoneal Dialysis	Travenol Laboratories, S.A.	FKO	Class II	1976-10-20
K760440	Catheter, Natural Latex Urethral	Akron Catheter, Inc.	KOD	Class II	1976-10-20
K760360	Shirt, Mitten Cuff Infant	Precept, Inc.	FME	Class I	1976-10-20
K760327	Wheel'n Weigh	Acme Medical Scale Co.	INF	Class I	1976-10-20
K760260	Bag, Disposable Urinary Leg	Intermed, Inc.	KNX	Class II	1976-10-20
K760069	Bag, Leg, Urine Collecting Device	Pharmaseal Div., Baxter Healthcare Corp.	KNX	Class II	1976-10-20
K760804	T-Pump, Temperature - Therapy Pump	Gaymar Industries, Inc.	ILO	Class II	1976-10-15
K760793	Adapter for Ellik Evacuator	V. Mueller O.V. Baxter Healthcare Corp.	FFD	Class I	1976-10-15
K760783	Biobond-Crown & Bridge Ceramic Bonding	Dentsply Intl.	EJS	Class II	1976-10-15
K760771	Sola Schultze-Crock Opthalmoscope	Cerenovus, Inc.	HLJ	Class II	1976-10-15
K760770	Sola Commido Loupe	Cerenovus, Inc.	HLJ	Class II	1976-10-15
K760768	Flexident Denture	Flexodent Corp.	EKO	Class II	1976-10-15
K760756	Battery Operated Flow Rate Computer	3M Health Care, Sarns	DXG	Class II	1976-10-15
K760755	Cutter Sil-Silicone Impression Mat	Cutter Laboratories, Inc.	ELW	Class II	1976-10-15
K760754	Cutter Tray-Acrylic for Imp Trays	Cutter Laboratories, Inc.	EBH	Class I	1976-10-15
K760752	Cutter Flex-Silicone Impression Mat.	Cutter Laboratories, Inc.	ELW	Class II	1976-10-15
K760735	Bongort Special Odorproof Drain	Howmedica Corp.	EXB	Class I	1976-10-15
K760716	Flexible Foreign Body Forceps	V. Mueller O.V. Baxter Healthcare Corp.	KOA	Class I	1976-10-15
K760640	Filter Set, Pmf 1024	Sorensen Research	KOC	Class II	1976-10-15
K760639	Filter Set, Pmf 2028	Sorensen Research	KOC	Class II	1976-10-15
K760638	Filter, Pmf 1000	Sorensen Research	KOC	Class II	1976-10-15
K760637	Filter Set, Pmf 1448	Sorensen Research	KOC	Class II	1976-10-15
K760633	Filter Set Pmf 1028	Sorensen Research	KOC	Class II	1976-10-15
K760632	Filter Set Pmf 2024	Sorensen Research	KOC	Class II	1976-10-15
K760631	Filter Set 1288	Sorensen Research	KOC	Class II	1976-10-15
K760630	Filter Set Pmf 200	Sorensen Research	KOC	Class II	1976-10-15