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 2026-11-05, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,132 of the 176,529 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	2,732

176,529 records, page 1925 of 3531

510(k) clearances, page 1925 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K964523	Recover Infant Heel Warmer (5100)	Florida Medical Industries, Inc.	MPO	Class I	1997-02-10
K964520	Parascan Scanning Device	Laserscope	GEX	Class II	1997-02-10
K964372	Cardiac T Troponin T Rapid Assay	Boehringer Mannheim Corp.	MMI	Class II	1997-02-10
K964260	Immage Immunochemistry System Kappa Light Chain (Kap) Reagent Immage Immunochemistry System Lamda Light Chain (Lam) Reag	Beckman Instruments, Inc.	DFH	Class II	1997-02-10
K964174	Mineral Trioxide Aggregate (Mta)	Tulsa Dental Products LLC	KIF	Class II	1997-02-10
K964010	Immage Immunochemistry System Apolipoprotein a-1 Reagent (Apa)/ Immage Immunochemistry System Apolipoprotein B Reagent	Beckman Instruments, Inc.	MSJ	Class I	1997-02-10
K964004	Glucometer Encore Blood Glucose Test Strips	Bayer Corp.	CFR	Class II	1997-02-10
K963868	Immage Immunochemistry System Immunoglobulin G (Igg), a (Iga) and M (Igm)	Beckman Instruments, Inc.	DEW	Class II	1997-02-10
K963866	Ambiderm (White Pow Latex Exam Gloves W/ Protein)	Supertex Industrial, S.A. de C.V.	LYY	Class I	1997-02-10
K963831	Sheathes (Non-Latex)	Medical Resources, Ltd.	ITX	Class II	1997-02-10
K963830	Sharps Container Model# Sc001	Image Medical, Inc.	FMI	Class II	1997-02-10
K963804	Patient Examination Gloves : Nitrile Examination Gloves	Hartalega Sdn Bhd	LZA	Class I	1997-02-10
K963730	Protec (1024)	Proportional Technologies, Inc.	KPS	Class II	1997-02-10
K962835	Heartport Endovenous Drainage Cannula	Heartport, Inc.	DWF	Class II	1997-02-10
K962828	Evert-It	Genesis Industries, Inc.	HGY	Class I	1997-02-10
K962576	Spline X Endosseous Dental Implant System	Calcitek, Inc.	DZE	Class II	1997-02-10
K962084	Omnican Syringe	B Braun Medical Inc	FMF	Class II	1997-02-10
K961974	Fg-36Ux, Ultrasound Upper Gi Fiberscope	Pentax Precision Instrument Corp.	ITX	Class II	1997-02-10
K961552	Cvp Polyurethane Catheter	Abbott Medical	FOZ	Class II	1997-02-10
K961321	Gamma Guidance System	Radiation Monitoring Devices, Inc.	IZD	Class I	1997-02-10
K946279	Prisma Cfm (Continuous Fluid Management System)	Cobe Renal Care, Inc.	KDI	Class II	1997-02-10
K941516	Ventanna Anti-Desmin Primary Antibody	Ventana Medical Systems Inc	DEH	Class II	1997-02-10
K941397	Anti-Vimentin Primary Antibody	Ventana Medical Systems Inc	DEH	Class II	1997-02-10
K970021	Rusch Suprapubic Tray	Rusch, Inc.	KOB	Class II	1997-02-07
K964964	Powder-Free Vinyl Patient Examination Gloves	Sunmax Enterprise Shanghai Co., Ltd.	LYZ	Class I	1997-02-07
K964927	Stabilizer Soft Tissue Anchor, 8Mm Model Ta1008, Anchor Inserter/suture Organizer, 8Mm Model Ai1008, Stabilizer Drill, 8	R. Thomas Grotz, M.D., Inc.	MBI	Class II	1997-02-07
K964899	Kendall Curity Ureteral Catheter	Kendall Healthcare Products Co. Div.Of Tyco Health	EYB	Class II	1997-02-07
K964723	Racal N95 Resirator	Racal Filter Technologies, Inc.	FXX	Class II	1997-02-07
K964722	Delta N95 Respirator	Racal Filter Technologies, Inc.	FXX	Class II	1997-02-07
K964701	Mitraflex Pigmented Wound Dressing	Polymedica Industries, Inc.	FRO	Unclassified	1997-02-07
K964672	Suture Applicator	Laurus Medical Group	GCJ	Class II	1997-02-07
K964495	Cefepine Antimicrobial Susceptibility Test Disc	Unipath, Ltd.	JTN	Class II	1997-02-07
K964492	Ciprofloxacin Antimicrobial Susceptibility Test Disc	Unipath, Ltd.	JTN	Class II	1997-02-07
K964491	Norfloxacin Antimicrobial Susceptibility Test Disc	Unipath, Ltd.	JTN	Class II	1997-02-07
K964490	Aztreonam Antimicrobial Susceptibility Test Disc	Unipath, Ltd.	JTN	Class II	1997-02-07
K964489	Cefaclor Antimicrobial Susceptibility Test Disc	Unipath, Ltd.	JTN	Class II	1997-02-07
K964487	Imipenem Antimicrobial Susceptibility Test Disc	Unipath, Ltd.	JTN	Class II	1997-02-07
K964315	Remel Staph Latex Kit	Remel, L.P.	JWX	Class I	1997-02-07
K964148	Patient Examination Gloves; Chlorinated Powderfree Nitrile Examination Gloves	Hartalega Sdn Bhd	LZA	Class I	1997-02-07
K963023	Ultrasound Gastroscope Gf Type Um30p	OLYMPUS Corporation of the Americas	FDS	Class II	1997-02-07
K962737	Ambiderm (Color Pow Latex Exam Gloves W/ Protein)	Supertex Industrial, S.A. de C.V.	LYY	Class I	1997-02-07
K962718	Femexam Testcard	Litmus Concepts, Inc.	CEN	Class I	1997-02-07
K962246	Rigid Fiber Optic Laparoscope	Health Care International Assoc.	HET	Class II	1997-02-07
K970176	Hcg Controls	International Newtech Development, Inc.	JJX	Class I	1997-02-06
K970009	Lyfo(tm) Differential Disk-Bacitracin	Microbiologics, Inc.	JTO	Class I	1997-02-06
K965169	Stablelin Enzyme Linearity Test Set C (Item No. 003)	Specialized Assays, Inc.	JJT	Class I	1997-02-06
K965038	Gore-Tex Soft Tissue Patch Plus/dualmesh Plus Biomaterial/mycromesh Plus Biomaterial/dualmesh Plus Biomaterial with Hole	W. L. Gore & Associates, Inc.	FTL	Class II	1997-02-06
K965007	Oratec Interventiouns Electrosurgical Probes	Oratec Interventions, Inc.	GEI	Class II	1997-02-06
K964786	Anchorlok Rl Soft Tissue Anchor System	Wrightmedicaltechnologyinc	MBI	Class II	1997-02-06
K964655	Uhmwpe Hip and Knee Components - Packaging Change	Howmedica Corp.	JDI	Class II	1997-02-06