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 3139 of 3528

510(k) clearances, page 3139 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K832248	Phadebact Strep Positive Controls	Pharmacia, Inc.	GTY	Class I	1983-09-01
K832102	Sterile Disposable Needles	Lee Medical Intl., Inc.	FMI	Class II	1983-09-01
K831971	Vivonex Tungsten Tip Tube-Twisted Wire	Norwich Eaton Pharmaceuticals, Inc.	KNT	Class II	1983-09-01
K831969	Vivonex Tungsten Tip Tube-Wound	Norwich Eaton Pharmaceuticals, Inc.	KNT	Class II	1983-09-01
K831968	Vivonex Tungsten Tip Tube-Braided	Norwich Eaton Pharmaceuticals, Inc.	KNT	Class II	1983-09-01
K831795	First Aid Kits	I M, Inc.	KDD	Class I	1983-09-01
K831441	Porocoat Freeman/samuelson Total Knee	Depuy, Inc.	MBV	Class II	1983-09-01
K831073	Dac-Cel Hcg-Mca Kit Rd52	Wellcome Diagnostics	CFL	Class I	1983-09-01
K832595	Vessel Dilator	Abbott Medical	DWP	Class II	1983-08-31
K832578	Monojet Samplette Adapters	Sherwood Medical Co.	GIO	Class I	1983-08-31
K832511	Reclining Wheels	Reclining Wheels	INN	Class I	1983-08-31
K832501	Enema Tube	Cone Instruments, Inc.	KNT	Class II	1983-08-31
K832445	Stratus Gentamicin Fluorometric Enzym	American Dade	LCD	Class II	1983-08-31
K832444	Enzymatic Triglycerides #2000	Stanbio Laboratory	CDT	Class I	1983-08-31
K832397	Hybritech 405-500 Nm Filter Module	Hybritech, Inc.	JJQ	Class I	1983-08-31
K832396	Central Venous Access Catheter Cvac	Gish Biomedical, Inc.	DOY	Class II	1983-08-31
K832383	Idt Ana Stiq Assay	Intl. Diagnostic Technology	DHN	Class II	1983-08-31
K832353	Corning's Magic T3(125i) Radioimmuno-	Corning Medical & Scientific	CDP	Class II	1983-08-31
K832337	Auto-TENS Model V	Cbc Corp.	GZJ	Class II	1983-08-31
K832336	Stratus Amikacin Fluorometric	American Dade	KLQ	Class II	1983-08-31
K832320	Prisma III	Dentsply Intl.	EBZ	Class II	1983-08-31
K832304	Braegen III 10-Channel Transmitter-	Electro-Bio-Medical Services, Inc.	GYE	Class II	1983-08-31
K832301	Direct Bonded Bracket Remover	Northwest Orthopedics	JCX	Class II	1983-08-31
K832296	S2 Posterior-Tib	Anstek Corp.	GXY	Class II	1983-08-31
K832295	S2median	Anstek Corp.	GXY	Class II	1983-08-31
K832291	Auto-Tach	Dentsply Intl.	DYH	Class II	1983-08-31
K832253	X-704	Unitek Corp.	EJS	Class II	1983-08-31
K832238	Neuromod Comfort Wave #7721 Dual-	Medtronic, Inc.	GZJ	Class II	1983-08-31
K832236	Sigma Procedure #550 Determ. Bilirub	Sigma Chemical Co.	CIG	Class II	1983-08-31
K832223	Periodontal Irrigator #7620	Vipont Laboratories, Inc.	EFS	Class I	1983-08-31
K832222	Pro Pulse Periodontal Irrigator 7618	Vipont Laboratories, Inc.	EFS	Class I	1983-08-31
K832193	Nice Pack	Universal Medical Instrument Corp.	IME	Class I	1983-08-31
K832112	No-Mix 30 Orthodontic Bonding System	Scientific Pharmaceuticals, Inc.	DYH	Class II	1983-08-31
K832062	Adaptic*fast Set Dental Restorative	Johnson & Johnson Professionals, Inc.	EBF	Class II	1983-08-31
K832061	Light Curing Bonding Agent	Johnson & Johnson Professionals, Inc.	EBF	Class II	1983-08-31
K832023	Embolectomy Catheter	Bionomy, Inc.	DXE	Class II	1983-08-31
K831975	Leading Edge Ophthalmic Knife	Surgidev Corp.	HNN	Class I	1983-08-31
K831847	Jejunostomy Kit	Accu-Line	KNT	Class II	1983-08-31
K831778	Rs-Residual Volume System	Warren E. Collins, Inc.	BZC	Class II	1983-08-31
K831777	Collins Ds	Warren E. Collins, Inc.	BZC	Class II	1983-08-31
K831381	Rapid Atrial Pacer	Seamed Corp.	DTE	Class II	1983-08-31
K831294	Solarcry/temporary Crown & Bridge Mat	Solar Dental Co., Inc.	EBG	Class II	1983-08-31
K831095	Royale II	Factor, II, Inc.	EBI	Class II	1983-08-31
K830863	Hancock Pericardial Patch	Extracorporeal Medical Specialities, Inc.	DXZ	Class II	1983-08-31
K832408	Stratus Tobramycin Fluorometric Enzym	American Dade	LCR	Class II	1983-08-26
K832364	Photon Immunoassay Analyzer	Hybritech, Inc.	JJQ	Class I	1983-08-26
K832307	Onpg Discs	Oxoid U.S.A., Inc.	JTO	Class I	1983-08-26
K832299	Visi-Flow Irrigator	Convatec, A Division of E.R. Squibb & Sons	EXD	Class II	1983-08-26
K832252	Clirans Taf06 Hollow Fiber Dialyzer	Terumo Medical Corp.	KOC	Class II	1983-08-26
K832143	Mark III Oxygen Walker Sys. Reservoir	Linde Div. Union Carbide Corp.	BYJ	Class II	1983-08-26