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 2026-10-08, 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 3341 of 3526

510(k) clearances, page 3341 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K801725	Kangaroo Enteral Feeding Pump	Chesebrough-Pond'S U.S.A. Co.	FRN	Class II	1980-08-13
K801723	Ur 150-Ur 150T	Siemens Corp.	KQS	Class I	1980-08-13
K801711	Bk-6010 Catheter Tube Holder	Fred Sammons, Inc.	KNX	Class II	1980-08-13
K801704	Open-Loop Insulin Delivery System	Delta Medical Industries	FRN	Class II	1980-08-13
K801690	Valiant	L.D. Caulk Co.	EJJ	Class II	1980-08-13
K801678	Spor-Test-Strip	Sterilization Technical Services, Inc.	FRC	Class II	1980-08-13
K801668	Quick Cept	Laboratory Diagnostics Co., Inc.	JHS	Class II	1980-08-13
K801660	Proximate * Psd Purse-String Device	Ethicon, Inc	GDJ	Class I	1980-08-13
K801651	Cutter Jet	Cutter Laboratories, Inc.	EFB	Class I	1980-08-13
K801648	Trimethroprim 5Mcg. Sensi Disc.	BD Becton Dickinson Vacutainer Systems Preanalytic	JTN	Class II	1980-08-13
K801638	A O Custom II Chair and Stand	American Optical Corp.	HME	Class I	1980-08-13
K801618	Argyle a-V Medi-Wing Hemodialysis Set	Sherwood Medical Co.	FIE	Class II	1980-08-13
K801614	Model 40-30-2 Air Eliminating Filter Set	Y	FPB	Class II	1980-08-13
K801609	Maddox Lens Spatula Cat. #7245	Edward Weck, Inc.	HND	Class I	1980-08-13
K801580	Ferritin Ria Kit	Siemens Healthcare Diagnostics Inc.	DBF	Class II	1980-08-13
K801560	Ventrex/sep Tsh Test Set	Ventrex Laboratories, Inc.	JLW	Class II	1980-08-13
K801503	Hollister Karaya Seal Ring	Hollister, Inc.	EXB	Class I	1980-08-13
K801499	Aga UV Photometer	Syva Co.	JJQ	Class I	1980-08-13
K801493	Ala Swab	Remel Co.	JTO	Class I	1980-08-13
K801492	Porphyrin (Ala) Disk	Remel Co.	JTO	Class I	1980-08-13
K801491	MRI Hcg-Beta Ria Kit Cat. #Mr-10100	Microanalytic Research, Inc.	JHI	Class II	1980-08-13
K801474	Trimethoprim 5Mcg. Sensitivity Discs	Difco Laboratories, Inc.	JTN	Class II	1980-08-13
K801428	Chemdi	American Sterilizer Co.	JOJ	Class II	1980-08-13
K801414	Erythrocath Intravenous Catheter Pla. U.	G.D. Searle and Co.	FOZ	Class II	1980-08-13
K801629	Cover-All Male Incontinence Device	The Urology Group	KNX	Class II	1980-08-12
K801613	Model 72-81-0 Unvented Solution Adm. Set	Y	FPA	Class II	1980-08-12
K801608	Mcculley Continuous Suture Tightner	Edward Weck, Inc.	HND	Class I	1980-08-12
K801605	Bimeco Filtered Extension Set	Burron Medical Products, Inc.	FPB	Class II	1980-08-12
K801561	Glycosylated Hemoglobin Kit	Amersham Corp.	LCP	Class II	1980-08-12
K801540	Mcgraw i.v. Administration Set	American Hospital Supply	FPA	Class II	1980-08-12
K801504	Hollister Drainage Pouch	Hollister, Inc.	FON	Class I	1980-08-12
K801468	Frazier-Ferguson Suction Tubes	Edward Weck, Inc.	KCB	Class I	1980-08-12
K801441	Abbott/shaw Life Care Pump Model 3	Abbott Medical	FRN	Class II	1980-08-12
K801431	Pan-Am Myelogram Tray	Waters Assoc., Inc.	FMI	Class II	1980-08-12
K801346	Nsi Reagent System for Ortho Elt-8 Hema	Nobel Scientific Industries, Inc.	GIF	Class I	1980-08-12
K801238	Accu-Pap T Zone Sampler	Robert Hasselbrack, M.D.	HFC	Class II	1980-08-12
K801227	Silicap	Vivadent (USA), Inc.	EMA	Class II	1980-08-12
K801220	Peritoneal Dialysis Cycler Set W/pump	American Medical Products LLC	KDJ	Class II	1980-08-12
K801194	Clirans Te07 Hollow Fiber Dialyzer	Terumo America, Inc.	FJI	Class II	1980-08-12
K801193	Clirans Te15 Hollow Fiber Dialyzer	Terumo America, Inc.	KDJ	Class II	1980-08-12
K801192	Clirans Te10 Hollow Fiber Dialyzer	Terumo America, Inc.	FJI	Class II	1980-08-12
K800993	Inpersol Capd Admin. Set & Catheter Adap	Abbott Medical	KDJ	Class II	1980-08-12
K800587	Nsi Wash Solution Concentrate	Nobel Scientific Industries, Inc.	JJC	Class I	1980-08-08
K801798	Composite Restorative, Paste/paste Type	Scientific Pharmaceuticals, Inc.	EBF	Class II	1980-08-07
K801797	Sci-Pharm Paint-on Restorative	Scientific Pharmaceuticals, Inc.	EBF	Class II	1980-08-07
K801788	Humerous Fracture Brace, Ulna Fracture	Hosmer Dorrance Corp.	IQI	Class I	1980-08-07
K801780	Oxy Custom Tray Resin	Oxy Dental Products, Inc.	EBH	Class I	1980-08-07
K801779	Oxydental Zinc Oxide Eugenol(zoe)cement	Oxy Dental Products, Inc.	EMB	Class I	1980-08-07
K801776	Cold Pack #589	Sunbeam Corp.	IME	Class I	1980-08-07
K801770	Arterial Bubble Trap	Delta Medical Industries	DWF	Class II	1980-08-07