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 2026-10-12, 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 3328 of 3528

510(k) clearances, page 3328 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K802537	Disposable Surgical Drape	Texas Medical Products, Inc.	KKX	Class II	1980-11-12
K802534	Gamma Pi Blood Group Substance	Gamma Biologicals, Inc.	KSX	Class II	1980-11-12
K802533	Gamma Lewis Blood Group Substance	Gamma Biologicals, Inc.	KSX	Class II	1980-11-12
K802524	Surgical Hammers	Midshore Welding Corp.	FZY	Class I	1980-11-12
K802521	Ck-Mb(immunological)	Biodynamics Corp.	JHS	Class II	1980-11-12
K802520	Centrifichem Pipettor Accuracy Calib.	Union Carbide Corp.	JQW	Class I	1980-11-12
K802518	Bun Reagent Astra 4 & 8 Analyzers	Nobel Scientific Industries, Inc.	CDN	Class II	1980-11-12
K802515	Root Canal Post	Unitek Corp.	ELR	Class I	1980-11-12
K802511	Garelick Commode	Garelick Mfg. Co.	ILS	Class I	1980-11-12
K802509	G.r.a.m. Slide	Sterilization Technical Services, Inc.	JTO	Class I	1980-11-12
K802506	Pleascent or Forma-Scent	Meridian Diagnostics, Inc.	IGG	Class I	1980-11-12
K802504	Sponge Surgical Guaze Radiopaque	Barnhardt Mfg. Co.	EFQ	Unclassified	1980-11-12
K802502	X & V Factor Discs	Oxoid U.S.A., Inc.	JTO	Class I	1980-11-12
K802501	V Factor Discs	Oxoid U.S.A., Inc.	JTO	Class I	1980-11-12
K802500	X-Factor Discs	Oxoid U.S.A., Inc.	JTO	Class I	1980-11-12
K802498	Mueller Hinton Agar	Oxoid U.S.A., Inc.	JTZ	Class II	1980-11-12
K802497	Bactiracin Diagnostic Disc	Oxoid U.S.A., Inc.	JTO	Class I	1980-11-12
K802496	Optochin Diagnostic Disc	Oxoid U.S.A., Inc.	JTO	Class I	1980-11-12
K802494	Gas Generating Kit System for Campylob.	Oxoid U.S.A., Inc.	KZJ	Class I	1980-11-12
K802493	Sputasol	Oxoid U.S.A., Inc.	IBG	Class I	1980-11-12
K802492	Reigning Artificial Teeth	Oki Shiks USA, Ltd.	ELM	Class II	1980-11-12
K802491	Reigning Repair Epoxy Resin	Oki Shiks USA, Ltd.	EBI	Class II	1980-11-12
K802489	Reigning Crown Bridge	Oki Shiks USA, Ltd.	EBG	Class II	1980-11-12
K802483	Ligmaject	Alan J. Khedarri D.D.S., Inc.	EJI	Class II	1980-11-12
K802473	Benzalkonium-Heparin Coated Guidewires	Medrad, Inc.	DQX	Class II	1980-11-12
K802471	Chemtroler	Fletcher Flora Computer Products, Inc.	JQP	Class I	1980-11-12
K802470	T3 Radioimmunoassay Kit	American Diagnostic Corp.	CDP	Class II	1980-11-12
K802469	T4 Radioimmunoassay Kit	American Diagnostic Corp.	CDX	Class II	1980-11-12
K802466	Disscap Hollow Fiber Dialyzer	Hospal Medical Corp.	FJI	Class II	1980-11-12
K802465	Bicarb-O-Mate Hemodialysis Sod. Bicarb.	Renal Systems, Inc.	FKR	Class II	1980-11-12
K802454	Geste Follow Kit Determ. of Hpl	Syn-Kit, Inc.	JMF	Class II	1980-11-12
K802431	Schuring Ossicle Cup & Columella Prosth.	Richard'S Medical Equip., Inc.	ETB	Class II	1980-11-12
K802423	Phadebact Haemophilus Test	Pharmacia, Inc.	GRO	Class II	1980-11-12
K802419	Ao Non-Contact II Tonometer	American Optical Corp.	HKX	Class II	1980-11-12
K802388	Major Dressing Tray-Milford Hosp.	American Medical Disposable, Inc.	EFQ	Unclassified	1980-11-12
K802387	Minor Dressing Tray-Milford Hosp.	American Medical Disposable, Inc.	EFQ	Unclassified	1980-11-12
K802386	Suture Wound Tray Milford Whittinsville	American Medical Disposable, Inc.	FMC	Class I	1980-11-12
K802385	Custom Dressing Tray-Wet to Dry/mass.	American Medical Disposable, Inc.	FPX	Class I	1980-11-12
K802384	Central Venous Catheter Dressing Tray	American Medical Disposable, Inc.	FPX	Class I	1980-11-12
K802383	Custom Dressing Tray/cardinal Cushing	American Medical Disposable, Inc.	EFQ	Unclassified	1980-11-12
K802373	Surgical Face Mask	Louis M. Gerson Co., Inc.	FXX	Class II	1980-11-12
K802369	12Ssl ECG Analysis Prog.(scaler Lead)	Marquette Electronics, Inc.	LOS		1980-11-12
K802333	Instant Bridge	Scientific Pharmaceuticals, Inc.	KLE	Class II	1980-11-12
K802330	Hi-Temp Looptip Surgical Cautery	Medical Products Development, Inc.	GEI	Class II	1980-11-12
K802267	Plt-4 Size-Check	R & D Systems, Inc.	JPK	Class II	1980-11-12
K802265	Cbc Plt-4	R & D Systems, Inc.	JPK	Class II	1980-11-12
K802243	Vaxiom Family of RF Lesion Probes & Elec	Progress Mankind Technology	GXI	Class II	1980-11-12
K802232	Ab-Trol Coagulation Control	Helena Laboratories, Corp.	GGW	Class II	1980-11-12
K802193	Kotex Security Tube Tampons	Kimberly-Clark Corporation	HEB	Class II	1980-11-12
K802191	Atgm Model at-80	Herald of America, Inc.	DXN	Class II	1980-11-12