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 3366 of 3526

510(k) clearances, page 3366 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K800234	Abco Suction Catheter & Kits W/glove&cup	Abco Dealers, Inc.	JOL	Class II	1980-02-26
K800233	Abco Midstream Urine Collection Set	Abco Dealers, Inc.	FMH	Class I	1980-02-26
K800231	Abco/grant Alternating Pressure Pad & Ut	Abco Dealers, Inc.	FNM	Class II	1980-02-26
K800230	Abco Examination Lamp (Gooseneck Type)	Abco Dealers, Inc.	KZF	Class I	1980-02-26
K800221	Cf/211 Capillary Flow Dialyzer, #5M1784	Travenol Laboratories, S.A.	FJI	Class II	1980-02-26
K800220	Calibrator No. 1 & 2, & Wash Solution	Fisher Scientific Company L.L.C.	JIT	Class II	1980-02-26
K800219	Serum Creatinine; Alk. Buffer & Picric	Fisher Scientific Company L.L.C.	CGX	Class II	1980-02-26
K800218	Carbon Dioxide Cup Reagent & Ref.rgt.	Fisher Scientific Company L.L.C.	JFL	Class II	1980-02-26
K800217	Chloride Reagent, Cup & Cleaner	Fisher Scientific Company L.L.C.	JFS	Class II	1980-02-26
K800216	Sodium/potassium Conditioning Reagent	Fisher Scientific Company L.L.C.	JGS	Class II	1980-02-26
K800213	Pharmacy Additive Syringe Set	Cutter Laboratories, Inc.	KYW	Class I	1980-02-26
K800201	Esophageal Pill-Electrode	Arzbaecher & Co.	DRX	Class II	1980-02-26
K800197	Anago Disp., All Purpose Patient Rest.	Anago, Inc.	FQM	Class I	1980-02-26
K800186	Logo-Nu-Way	Gary Giancarlo	KNX	Class II	1980-02-26
K800109	Surgitek Urinary Diversion Stent	Medical Engineering Corp.	FAD	Class II	1980-02-26
K792529	Point Locator Stimulator	Staodynamics, Inc.	BWJ	Class II	1980-02-26
K792501	Pls Mini	Staodynamics, Inc.	BWJ	Class II	1980-02-26
K792395	Pharmaflex Cryogenic Bag	Pharmachem Corp.	KSR	Class II	1980-02-26
K800046	Ldc Chromatography Accessory Module B	Laboratory Data Control	KIE	Class I	1980-02-25
K792062	Theophylline Riassay	Ria Diagnostics	LCA	Class II	1980-02-25
K800324	Volu-Sol Harris Hematoxylin	Volu Sol Medical Industries	HYK	Class I	1980-02-22
K800323	Volu-Sol Orange G-6 Stain	Volu Sol Medical Industries	HZH	Class I	1980-02-22
K800313	Sagittal Saw	Black & Decker(Tm)	KIJ	Class I	1980-02-22
K800312	150 Driver/reamer	Black & Decker(Tm)	KIJ	Class I	1980-02-22
K800311	450 Drill/800 Drill	Black & Decker(Tm)	KIJ	Class I	1980-02-22
K800237	Folding Crutch	Husa Folding Crutch Co., Inc.	IPR	Class I	1980-02-22
K800236	Abco Mercurial Sphygmomanometer	Abco Dealers, Inc.	DXQ	Class II	1980-02-22
K800224	Radiometer Acid Base Laboratory-Abl-3	The London Co.	CHL	Class II	1980-02-22
K800209	Boots - Outdoor Carrier for the Amigo	Amigo Sales, Inc.	ITI	Class II	1980-02-22
K792670	Smith Subtalar Peg	Dow Corning Wright	LXH	Class I	1980-02-22
K792610	Kallestad Florescent Ana/ama/asma Test	Kallestad Laboratories, Inc.	DBL	Class II	1980-02-22
K792490	Uca Lotion	Vanaray Laboratories, Inc.			1980-02-22
K792436	Vxtra Back Pack EKG Electrode Cat. No.	Vxtra Corp.	DRX	Class II	1980-02-22
K800268	Automated Rhematoid Factor Test (Arft)	BD Becton Dickinson Vacutainer Systems Preanalytic	DHR	Class II	1980-02-21
K800239	Rh-Hr Negative Control Reagent	Gotham Biologics, Inc.	KSF	Class II	1980-02-21
K800232	Abco Ultra Slide Microscope Slide	Abco Dealers, Inc.	KEW	Class I	1980-02-21
K800229	Immunop. Antimitochondrial Antibody Kit	Clinical Sciences, Inc.	DBM	Class II	1980-02-21
K800228	Immunop. Antismooth Muscle Antibody Kit	Clinical Sciences, Inc.	DBE	Class II	1980-02-21
K800208	Skil-Care Leg Pads	Skil-Care Corp.	KNO	Class I	1980-02-21
K800200	Linear Enzymatic Glucose System	Simmler Inc	CGA	Class II	1980-02-21
K800199	Linear Enzymatic Cholesterol System	Simmler Inc	CHH	Class I	1980-02-21
K800178	Extracorp.'s Intersept Cus. Tubing Pk.	Extracorporeal Medical Specialities, Inc.	DWE	Class II	1980-02-21
K800175	Nasostat	Edward Weck, Inc.	EMX	Class I	1980-02-21
K800155	Disposal Liter Breathing Bag	Dryden Corp.	BTC	Class I	1980-02-21
K800100	7200 Ma Echo-Ophthalmoscope	Kt Medical, Inc.	IYO	Class II	1980-02-21
K800099	Intracula II	Kt Medical, Inc.	IYO	Class II	1980-02-21
K792528	Respiration/apnea Amplifier Model 3105	Electronics for Medicine, Inc.	BZQ	Class II	1980-02-21
K791160	Dentaleen	Denpac Corp.	EMA	Class II	1980-02-21
K800293	File, Pulp Canal	Ipco Corp.	EKS	Class I	1980-02-19
K800292	Endex Broach, Endodontic	Ipco Corp.	EKW	Class I	1980-02-19