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 2807 of 3530

510(k) clearances, page 2807 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K871515	Sl-100 Nd:yag Laser for Gastrointestinal Bleeding	Medical Energy, Inc.	LNK	Class II	1987-07-09
K871514	Sl-100 Nd:yag Laser for Rectal Patho. & Hemorrhoid	Medical Energy, Inc.	LNK	Class II	1987-07-09
K871513	Sl-100 Nd:yag Laser for Palliation of Gastro. Mali	Medical Energy, Inc.	LNK	Class II	1987-07-09
K871458	Survival Kit, Individual, Trop, Tactical Air Crew	Fraass Survival Systems, Inc.	KDD	Class I	1987-07-09
K871437	Survival Kit, Individual	Fraass Survival Systems, Inc.	LRO	Class II	1987-07-09
K871434	Medical Packet, Individual Survival Kit, Airman's	Fraass Survival Systems, Inc.	LRO	Class II	1987-07-09
K865083	Affinity(tm) I Uptake Immunit(tm)	BD Becton Dickinson Vacutainer Systems Preanalytic	KHQ	Class II	1987-07-09
K864912	Pds (Polydioxanon) Absorbable Pin	Johnson & Johnson Professionals, Inc.	HTY	Class II	1987-07-09
K871904	Total Lung Exerciser (Tle)	MBA Healthcare Products, Inc.	BWF	Class II	1987-07-08
K871628	Palex (R) Ostomy	Industrias Palex C/O Dma Med-Chem Corp.	EXB	Class I	1987-07-08
K871424	Endocoagulator Model 5, 8 & 20 Argon Laser	Hgm, Inc.	LMS	Class II	1987-07-08
K870889	Acid Fuchsin Solutions	D.R.G. Scientific Industries	FKQ	Class II	1987-07-08
K872347	Digoxin Fpia Controls	Sigma Diagnostics, Inc.	LAS	Class I	1987-07-07
K872328	Digoxin Fpia Calibrators	Sigma Chemical Co.	DLJ	Class II	1987-07-07
K872304	Unassayed Control Serum, Normal (Bovine)	Vanguard Diagnostic Systems	JJY	Class I	1987-07-07
K872303	Unassayed Control Serum, Abnormal (Bovine)	Vanguard Diagnostic Systems	JJY	Class I	1987-07-07
K872273	Corning Easy Wash Elisa Plates	Corning Medical & Scientific	LIB	Class I	1987-07-07
K872243	Pekalux(tm)	Columbus Dental Mfg. Co.	EBF	Class II	1987-07-07
K872180	Kinetic 610 Ethanol	American Monitor Corp.	DML	Class II	1987-07-07
K872157	Hall Vein Stripper	Solco Basle, Inc.	DWQ	Class II	1987-07-07
K872050	Paramax Cholesterol Reagent	American Dade	LBS	Class I	1987-07-07
K872030	Uni-Fast Lactate Dehydrogenase (Ldh-L)	Sclavo, Inc.	CFJ	Class II	1987-07-07
K871694	Hyperformance Controls (Hp-Controls)	Rapid Diagnostic Laboratories, Inc.	DIF	Class I	1987-07-07
K871406	The Woog Orabrush	Woog Intl.	JEQ	Class I	1987-07-07
K872360	Data-Fi Fibrin(ogen) Degradation Prod.(fdp)det Set	American Dade	GHH	Class II	1987-07-06
K872227	Liquichek Pediatric Control Levels I and II	Bio-Rad	JJY	Class I	1987-07-06
K871388	Micromat Model 415 - Bichromatic Filter Photometer	Bio-Rad	LCP	Class II	1987-07-06
K865010	Micor	Siemens Medical Solutions USA, Inc.	DQK	Class II	1987-07-06
K872475	Surgical Bur	Tava Surgical Instruments	GFF	Class I	1987-07-02
K872395	Ck 1600 Series, Towels	Currie Medical Specialties, Inc.	KKX	Class II	1987-07-02
K872386	C Clamp	Med-Tool, Inc.	HXD	Class I	1987-07-02
K872384	Side Cutting Parallel Action Pliers	Med-Tool, Inc.	HTC	Class I	1987-07-02
K872313	Needle & Blade Counter & Disposal Unit	Gary Plastic Packaging Corp.	MMK	Class II	1987-07-02
K872279	Scotchbond 2 Adhesive W/scotchprep Dentin Primer	3M Company	EBF	Class II	1987-07-02
K872272	Pekalux/gluma Light Cured Anterior Restorative Sys	Columbus Dental Mfg. Co.	EBF	Class II	1987-07-02
K872251	Abrasive Disc - Polishing Wheel	Dentsply Intl.	EJR	Class I	1987-07-02
K872112	Xomed Platinum Wire Teflon Pistion	Xomed, Inc.	ETB	Class II	1987-07-02
K871837	Coulter Counter Model S-Plus Stkr	Coulter Electronics, Inc.	GKZ	Class II	1987-07-02
K871818	Spatula, Dental, Cement	Military Engineering, Inc.	EJB	Class I	1987-07-02
K871636	Clearfil Porcelain Bond	Kuraray Co.	KLE	Class II	1987-07-02
K871164	Gluma(tm) Bonding System	Columbus Dental Mfg. Co.	EBF	Class II	1987-07-02
K864540	Plak Vak - Pv-10	Paul S. Barclay, D.D.S., Ltd.	EFS	Class I	1987-07-02
K872468	Jovi Myelography Harness	Jovi, Inc.	KPR	Class II	1987-07-01
K872305	Irma-Count Tsh Rkts1, Rkts2, Rkts5, Rktsx	Siemens Healthcare Diagnostics Inc.	JLW	Class II	1987-07-01
K872252	Modified Toxoplasma Gondii Igg Eia Test Kit	Labsystems, Inc.	LGD	Class II	1987-07-01
K872110	Easy-Test Ammonia (Amon) Item No. 16695	Em Diagnostic Systems, Inc.	JIF	Class I	1987-07-01
K872053	Keyfill	Mayfield Instruments, Ltd.	CAD	Class II	1987-07-01
K871567	Phenytoin Fpia Controls	Sigma Diagnostics, Inc.	LAS	Class I	1987-07-01
K871550	Pfi-20 Polarizing Fluorimeter	Revvity Health Sciences, Inc.	KHO	Class I	1987-07-01
K871500	Model 5000 Ambulatory Monitoring System	Oxford Medilog, Inc.	GWQ	Class II	1987-07-01