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 3349 of 3526

510(k) clearances, page 3349 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K801101	Analor Four-Oral Surgery Model	Narco Mckesson Co.	BZE	Class II	1980-06-17
K801088	F.r.c. Apparatus	Hogan/Cologne Ent.	BZC	Class II	1980-06-17
K801074	Straith Nasal Implant	Surgical Technology Laboratories Inc.	FZE	Class II	1980-06-17
K801072	Straith Nasal Splint	Surgical Technology Laboratories Inc.	FYI	Class I	1980-06-17
K801057	3M Steam Sterilization Indicator	3M Company	JOJ	Class II	1980-06-17
K801022	Ultra-Chek Pacemaker Monitor	Powers Medical Systmes	KRE	Class II	1980-06-17
K801017	Tanit Commercial Suntan Booth	Tanit, Inc.	FTC	Class II	1980-06-17
K800879	Clear Plastic Connecting Tubes	Harvard Laboratories	FPK	Class II	1980-06-17
K800878	Secondary i.v. Tubing Sets	Harvard Laboratories	FPA	Class II	1980-06-17
K800877	Anesthesia Extension Tubes	Harvard Laboratories	FPK	Class II	1980-06-17
K800845	Bronzage Tanning System	Bronzage Rapide			1980-06-17
K800843	Medefizz a & Medefizz B	Medefield Pty., Ltd.	KTA	Unclassified	1980-06-17
K800840	Medefoam-2	Medefield Pty., Ltd.	KTA	Unclassified	1980-06-17
K800822	CO2 Cystoscopy/urethroscopy Console	Kli	FAP	Class II	1980-06-17
K800366	Solarium, Model 6040A	Blendette Intl., Ltd.			1980-06-17
K801329	Anspach Instrument Caddy	The Anspach Effort, Inc.	HSZ	Class I	1980-06-09
K801328	The Equalizer	The Anspach Effort, Inc.	MDM	Class I	1980-06-09
K801327	The Extractor I Tm	The Anspach Effort, Inc.	HWB	Class I	1980-06-09
K801313	Compression Molding of Uhmwpe	Howmedica Corp.			1980-06-09
K801274	S.s. White-Pennwalt Prelude Pit Sealant	Pennwalt Corp.	EBC	Class II	1980-06-09
K801271	Model 4900 Off-Line Preparation System	Pm America, Inc.	JQW	Class I	1980-06-09
K801261	Disposable Coupling Adaptor	Intec Medical, Inc.	BYX	Class I	1980-06-09
K801259	Needle Counter-Sure Count/100 Count	Kleen Test Products Corporation	MMK	Class II	1980-06-09
K801254	Penlon I.d.p. Presssure Failure Alarm	Penlon, Ltd.	CAP	Class II	1980-06-09
K801237	Reigning Crown-Bridge/polycarb. Resin	Oki Shiks USA, Ltd.	EBF	Class II	1980-06-09
K801234	Reigning Denture Made of Polycarb. Resin	Oki Shiks USA, Ltd.	EBI	Class II	1980-06-09
K801223	Pentex Fexible Colonscope, Mod. Fc-34A	Pentax Precision Instrument Corp.	FDF	Class II	1980-06-09
K801221	Thora-Drain III Plastic Drainage System	Chesebrough-Pond'S U.S.A. Co.	KDQ	Class II	1980-06-09
K801205	Emit Disopyramide Control	Syva Co.	LAS	Class I	1980-06-09
K801204	Emit Disopyramide Assay	Syva Co.	KLR	Class II	1980-06-09
K801203	Cortisol Radioimmunoassay Kit	Technia Diagnostics, Ltd.	CGR	Class II	1980-06-09
K801195	Dermalex or Natrawool Skin Pressure Prot	Stock Wild & Co.	FMP	Class I	1980-06-09
K801188	Conphar Desk Top Mercury Sphygmoman	Conphar, Inc.	DXQ	Class II	1980-06-09
K801187	Conphar Checkmate Sphygmomanometer	Conphar, Inc.	DXN	Class II	1980-06-09
K801186	Conphar Deluxe Aneroid Sphygmomanometer	Conphar, Inc.	DXQ	Class II	1980-06-09
K801167	Centrifichem System 400	Union Carbide Corp.	JQP	Class I	1980-06-09
K801155	Technicon H6000 Hematology System	Technicon Instruments Corp.	GKL	Class II	1980-06-09
K801148	Hemogastat	Therapac, Inc.	JRR	Class I	1980-06-09
K801145	Smi Multi-Tube Vortexer	Scientific Manufacturing Industries	JRQ	Class I	1980-06-09
K801144	Ethox/barron Food Pump Gavage Bag Sets	Ethox Corp.	FHT	Class II	1980-06-09
K801139	Centrifichem System 500 Analyzer	Union Carbide Corp.	JJG	Class I	1980-06-09
K801125	Spac T3 Ria Test Kit	Mallinckrodt Critical Care	CDP	Class II	1980-06-09
K801123	Triiodothyronine Radioimmun. System	Calbiochem-Behring Corp.	CDP	Class II	1980-06-09
K801119	Cobas Reagent for Alt (Gpt)	Roche Analytical Instruments, Inc.	CKA	Class I	1980-06-09
K801117	Cobas Total Bilirubin Reagent & Diluent	Roche Analytical Instruments, Inc.	CIG	Class II	1980-06-09
K801105	Thyroxine Radioimmunoassay Kit	Calbiochem-Behring Corp.	CDX	Class II	1980-06-09
K801096	Perkin Elmer Model 91 Amylase Reagent	Stat Engineering	KHM	Class II	1980-06-09
K801094	Silastic Hammertoe Implant (Swanson-Well	Dow Corning Corp. Healthcare Industries Materials	KWH	Class II	1980-06-09
K801091	K 750 Computer/data Processor	J.T. Baker Chemical Co.	JQP	Class I	1980-06-09
K801090	J.t. Baker Lsa 290 Pipetter/diluter	J.T. Baker Chemical Co.	JQW	Class I	1980-06-09