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 2026-10-26, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 2701 of 3530

510(k) clearances, page 2701 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K882154	Hepax (TENS)	Avl Scientific Corp.	GZJ	Class II	1988-09-30
K881863	Rep Glyco System	Helena Laboratories, Corp.	LCP	Class II	1988-09-30
K881350	Cbc/constavac Blood Conservation System	Stryker Corp.	CAC	Class II	1988-09-30
K881177	Model Meb-5304 Evoked Potential & Electro. Record	Nihon Kohden America Inc	GWL	Class II	1988-09-30
K880378	Lota, Lifecare Oxygen/temperature Analyzer 36-001	Lifecare Services, Inc.	CCL	Class II	1988-09-30
K875258	Toxoplasma Gondii Igg Elisa Kit	De Ferris Laboratories, Inc.	LGD	Class II	1988-09-30
K874180	Colorectal Cancer Risk Detector (Tm)	Pearce Clinical Laboratories, Inc.	KHE	Class II	1988-09-30
K883950	Modified Toob-Cheq Carbon Dioxide Gas Analyzer	Fenem, Inc.	CCK	Class II	1988-09-29
K883858	Fiberoptic Sharp Integral Pick Lightpipe	Advanced Surgical Products, Inc.	HBI	Class II	1988-09-29
K883857	Fiberoptic Wire Pick Lightpipe	Advanced Surgical Products, Inc.	HBI	Class II	1988-09-29
K883856	Fiberoptic Blunt Integral Pick Lightpipe	Advanced Surgical Products, Inc.	HBI	Class II	1988-09-29
K883612	Lectrospiral	Vygon Corp.	FPA	Class II	1988-09-29
K883589	Gambro Alwall Gfe 12 & 18 Hollow Fiber Dialyzer	Gambro, Inc.	FJI	Class II	1988-09-29
K883490	Accuflo Uf Control Module No. 74-0100-3	National Medical Care, Medical Products Div., Inc.	FJB	Class II	1988-09-29
K883374	Bard Biopsy Needle Guidance Device	C.R. Bard Inc	KNW	Class II	1988-09-29
K883280	Hologic Qdr-1000 X-Ray Bone Densitometer/modified	Hologic, Inc.	KGI	Class II	1988-09-29
K883227	Skifa, Plastic Disposable Syringe	P.T. Setio Harto, Ltd.	FMF	Class II	1988-09-29
K883023	Modified Ultra-Fresh Odor Reducing Compound	Mentor	GDS	Class I	1988-09-29
K883008	Pulmonary Forced Flow System (Puffs)	Medical Associated Services, Inc.	BTY	Class II	1988-09-29
K882887	Progel(tm), Models 8630 and 8635	Medical Devices Inc.	GXY	Class II	1988-09-29
K882886	Progel (Tm) Dual Electrode Pad, Model 8535	Medical Devices Inc.	GXY	Class II	1988-09-29
K882418	Dry Comfort Undergarment	Health Tec, Inc.	EYQ	Class I	1988-09-29
K882054	Hystero Kit	Zinnanti Surgical Instruments, Inc.	HDP	Class II	1988-09-29
K880548	Safe-Strips	Medstar, Inc.	JOJ	Class II	1988-09-29
K883952	U. V. Sunlamp 95Uf-11	Light Sources, Inc.	FTC	Class II	1988-09-28
K883944	Mec-1 Video Combo System	Medical Concepts	FTS	Class I	1988-09-28
K883943	Ccm-1 Video Camera System	Medical Concepts	FTS	Class I	1988-09-28
K883760	Storz Model 62 ENT Camera System	Storz Instrument Co.	FWL	Class I	1988-09-28
K883744	Manan Huber Style Infusion Needle	Argon Medical Devices, Inc	FMF	Class II	1988-09-28
K883685	Immuno/febrile Antigens	Immunostics, Inc.	GNC	Class II	1988-09-28
K883684	Herpes Virus Control Slides	Val Tech Diagnostics, Inc.	GQN	Class II	1988-09-28
K883429	Lindstrom Cordless Epilator	A Place of Health & Beauty	KCW	Class I	1988-09-28
K883376	Sterilization Wrap Type 22,44,77	East Texas Lighthouse for the Blind	FRG	Class II	1988-09-28
K883345	Sarns Infant Venous Reservoir Model #16387	3M Health Care, Sarns	DTN	Class II	1988-09-28
K883149	Ten20 Conductive	Weaver & Co.	GYB	Class II	1988-09-28
K883089	4000/4900/6000/8000/8900 Nd:yag/1700 Nd:yag C02	Heraeus Lasersonics, Inc.	GEX	Class II	1988-09-28
K883000	Acs Angioscope Guide Wire	Advanced Cardiovascular Systems, Inc.	LYK	Class II	1988-09-28
K882925	Acs Schwarten Xt Balloon Dilatation Catheter	Advanced Cardiovascular Systems, Inc.	LIT	Class II	1988-09-28
K881825	Models Sp5825/sp5835/sp5845/sp5855 Percu. Sheath	Spectramed, LLC	DYB	Class II	1988-09-28
K881780	Vascucare Angiopump	Vascucare, Inc.	DWB	Class II	1988-09-28
K874818	Tenstar	Healthcheck Corp.	GZJ	Class II	1988-09-28
K883762	Bard Ems Systems 3400 & 4400 & Dual Pad Electrode	Bard Electro Medical Systems, Inc.	GEI	Class II	1988-09-27
K883563	Sharplan 2100 Nd:yag Laser, Series 2900 Syn. Tips	Sharplan Lasers, Inc.	GEX	Class II	1988-09-27
K883551	Sceptor Staphylococcus Mic/id Panel #80325	BD Becton Dickinson Vacutainer Systems Preanalytic	JWY	Class II	1988-09-27
K883360	Hologic Model Whf-1 Anthropomorphic Femur Phantom	Hologic, Inc.	KGI	Class II	1988-09-27
K883320	Monoject(r) Trace Element Blood Collection Tube	Sherwood Medical Co.	JKA	Class II	1988-09-27
K882981	Pti Intra-Art Coronary Artery Retraction Clip	Pioneering Technologies, Inc.	DWS	Class I	1988-09-27
K882928	Tad Intermediate & Tad Standard Guide Wire	Advanced Cardiovascular Systems, Inc.	DQX	Class II	1988-09-27
K882892	Membrane Oxygenator	Baxter Bentley Laboratories, Inc.	DTZ	Class II	1988-09-27
K882809	Thymapad	Somatics, LLC	GXY	Class II	1988-09-27