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 2026-10-21, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 3015 of 3529

510(k) clearances, page 3015 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K844934	Azide Agar W/5% Sheep Blood	American Laboratory Supply, Inc.	JSI	Class I	1985-02-25
K844893	Slt 223 Dispenser for Microtiterplates	Slt Labinstruments, Inc.	JTC	Class I	1985-02-25
K844892	Slt 220 Washer for Microititerplates	Slt Labinstruments, Inc.	JTZ	Class II	1985-02-25
K844891	Slt 225 Washer/dispenser for Micro Titerplates	Slt Labinstruments, Inc.	JTC	Class I	1985-02-25
K844887	Identification Sticks Oxidase	Oxoid U.S.A., Inc.	JTO	Class I	1985-02-25
K844878	Trypsin 10X - 1:250 in Hbss W/o Ca & Mg	Hazleton Research Products, Inc.	KIP	Class I	1985-02-25
K844877	Hepes Buffer Im in Normal Saline	Hazleton Research Products, Inc.	KIP	Class I	1985-02-25
K844808	Methyl Green-Pyronin Stain Procedure Ht70	Sigma Chemical Co.	HZA	Class I	1985-02-25
K844671	Corning Disposal Sterile Filter System-Nylon	Corning Medical & Scientific	KET	Class I	1985-02-25
K844659	Vps 2250, Csu2250 & Vfu 2250	Madsen Electronics (Canada), Ltd.	GWE	Class II	1985-02-25
K844580	Medcolator Model Hvx	Medco Products, Co., Inc.	IPF	Class II	1985-02-25
K844431	Yn CO2 Laser System 30W	Cryomedics LLC	HHR	Class II	1985-02-25
K844338	1Uro-Log Home Diagnostic Pack	Epcom Medical Systems, Inc.	FFG	Class II	1985-02-25
K844297	Supplemental Feeding System	Medela AG	HGY	Class I	1985-02-25
K844189	Linear Scanner Probe Elscint Ltd. Tl-35	Elscint, Inc.	IYP	Class I	1985-02-25
K844128	Eub-40	Hitachi Medical Corp. of America	JAF	Class II	1985-02-25
K843964	TENS-Aid Premium Electrodes	Staodynamics, Inc.	GXY	Class II	1985-02-25
K843941	Endocyte	Gyneco, Inc.	HFE	Class II	1985-02-25
K843205	Gl Ultrasound Z/sl 8300	Gl Ultrasound, Ltd.	IYO	Class II	1985-02-25
K841803	A1 Systeme 8201/2	Med USA	GKL	Class II	1985-02-25
K850657	Thermal Diffusion Cerebral Blood Flow Monitor	Flowtronics, Inc.	LME	Class III	1985-02-22
K850114	C/pes 9201, ECG Stress Testing Sys	Gould, Inc.	DRT	Class II	1985-02-22
K850112	Omnimed IV Solution Administration Set	Omni Intl., Inc.	FPA	Class II	1985-02-22
K850098	Silver Spoon Enteral Feeding Pump	Sterling Medical Devices, Inc.	FRN	Class II	1985-02-22
K844904	Cytosafe Needle	Baxa Corp., Sub. of Cook Group, Inc.	LHI	Class II	1985-02-22
K844672	Instrutainer	Intrumed, Inc.	FRG	Class II	1985-02-22
K844467	Oms Cryo	Optical Micro Systems, Inc.			1985-02-22
K850406	Automatic Peritoneal Dialysis Cycler System	Travenol Laboratories, S.A.	FKX	Class II	1985-02-21
K850206	Philips UV-a Solarium Type Hp 3126-Sunlamp	Philips Int'L B.V.	FTC	Class II	1985-02-21
K850205	Philips UV-a Solarium Type Hp 3127-Sunlamp	Philips Int'L B.V.	FTC	Class II	1985-02-21
K850204	Philips UV-a Solarium Type Hp 3130-Sunlamp	Philips Int'L B.V.	FTC	Class II	1985-02-21
K850203	Philips UV-a Solarium Type Hp 3016-Sunlamp	Philips Int'L B.V.	FTC	Class II	1985-02-21
K850199	Poly-Lined Towel/drape Line	Excel Health Care Products	KKX	Class II	1985-02-21
K850184	Medical Multi-Image Camera-676	Dunn Instruments, Inc.	LMC	Class II	1985-02-21
K850177	Matrix Dri-Idea (Plastic Dispos. Surgical Gown)	Matrix Medica, Inc.	FYA	Class II	1985-02-21
K850150	Ulster Scientific, Inc. Autolet Lancets/gainor Med	Gainor Medical	FMK	Class II	1985-02-21
K850122	Soni-Lok Scope Stabilizer	Med Surg Designs, Inc.	FXR	Class I	1985-02-21
K850093	Panamedic Gauze Sponges	General Electric Trading Co.	EFQ	Unclassified	1985-02-21
K850063	Instrument Pocket	E.M. Adams Co., Inc.			1985-02-21
K850041	P-3 Closing Instrument	Lone Star Medical Products			1985-02-21
K845041	Capd Staged Connector	Abbott Medical	FKO	Class II	1985-02-21
K845005	Brooker Acetabular Cup	Zimmer GmbH	JDI	Class II	1985-02-21
K845001	Martanique 6-Tube Home Solarium	Bainbridge Trading Co., Ltd.	FTC	Class II	1985-02-21
K844873	Pennine Guedel Airway 00,0,1,2,3 & 4	Pennine Medical, Ltd.	CAE	Class I	1985-02-21
K844574	Wheelchairs	Medicon Co., Ltd.	IOR	Class I	1985-02-21
K844565	Bovie X-10 Electrosurgical Generator(unit)	Clinical Technology Inc.	GEI	Class II	1985-02-21
K844554	Belmont Autopan-Panoramic 098 Cephalometric-Radiog	Belmont Equipment Corp.	IWZ	Class I	1985-02-21
K844490	Traction Accessories	Jerome Medical	ILZ	Class I	1985-02-21
K844466	The Probe 100	Rich-Mar Corp.	IPF	Class II	1985-02-21
K844424	Independent Jaw Mode Option for Varian Clinac 4/10	Varian Assoc., Inc.	JAD	Class II	1985-02-21