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 1703 of 3531

510(k) clearances, page 1703 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K993590	Fructosamine Reagent Set, Calibrator, and Control Set	Horiba Instruments Incorporated	LCP	Class II	1999-12-21
K993381	Tongue Stabilizer Device	University of Otago	LRK	Class II	1999-12-21
K993359	Raptor Treatment Planning System	Nomos Corp.	IYE	Class II	1999-12-21
K993227	Philips Inturis Dicom Recorder	Philips North America LLC	LLZ	Class II	1999-12-21
K993107	Bio-Rad Homocysteine by Hplc	Bio-Rad	LPS	Class II	1999-12-21
K992954	Keeler Cryo Master & Probes	Keeler Instruments, Inc.	HRN	Class II	1999-12-21
K992502	Axis %Cdt Turbidimetric Immunoassay	Axis	NAO	Class I	1999-12-21
K992456	Gradileiden V Test	Gradipore, Ltd.	GGW	Class II	1999-12-21
K992232	First Response 1-Step Pregnancy	Armkel, LLC	LCX	Class II	1999-12-21
K991697	Uni-Gold H. Pylori	Trinity Biotech, PLC	LYR	Class I	1999-12-21
K991074	Bartels Legionella Urinary Antigen Elisa Test	Intracel Corp.	MJH	Class II	1999-12-21
K990899	Hemochek-A1c Sample Collection Kit	Osborn Group, Inc.	LCP	Class II	1999-12-21
K990258	Quantech Total B-Hcg Assay	Quantech, Ltd.	NAL	Class II	1999-12-21
K990173	Pathfinder II Angiographic Catheter	Maxxim Medical	DQO	Class II	1999-12-21
K981784	Igm Minineph Antiserum	The Binding Site	CFN	Class II	1999-12-21
K980760	Kls-Martin Mmf Screw	KLS-Martin L.P.	DZL	Class II	1999-12-21
K994096	Sonoheart Hand-Carried Echocardiography System	FUJIFILM SonoSite,Inc.	IYN	Class II	1999-12-20
K994053	Stryker T4 Power Pack, Stryker T4 Eight Station Battery Charger, Stryker T4 Charger Module	Stryker Corp.	FYA	Class II	1999-12-20
K994036	Pre-Powdered Vinyl Exam Glove, Non Sterile	Shanghai Champion Plastic Products Co., Ltd.	LYZ	Class I	1999-12-20
K993975	Absolute Absorbable Interference Screw	Innovasive Devices, Inc.	HWC	Class II	1999-12-20
K993956	Titanium Pediatric Femoral Nail	Zimmer GmbH	HSB	Class II	1999-12-20
K993888	A & D Medicallifesource US-779Pc & Ua-779T Digital Blood Pressure Monitors	A and D Engineering, Inc.	DXN	Class II	1999-12-20
K993887	Alatech Latex Condom	Alatech Healthcare, LLC	HIS	Class II	1999-12-20
K993668	Laerdal Suction Unit,(4000) Model 78 00 20	Laerdal Medical a/S	BTA	Class II	1999-12-20
K993605	Pepper Green Mint Powdered Latex Examination Gloves	Top Glove Sdn. Bhd.	LYY	Class I	1999-12-20
K993452	Green Powdered Latex Examination Gloves	Top Glove Sdn. Bhd.	LYY	Class I	1999-12-20
K993449	Bird V.i.p. Gold/sterling	Bird Products Corp.	CBK	Class II	1999-12-20
K993432	Rossmax Automatic Wristwatch Blood Pressure Monitor, Model Z46	Rossmax International Ltd.	DXN	Class II	1999-12-20
K993402	Opus Spinal System	Howmedica Osteonics Corp	MNI	Class II	1999-12-20
K993386	Latex Examination Powdered Gloves	Great Glove Sdn Bhd	LYY	Class I	1999-12-20
K993375	Cds Ltx Control Latex Particle Suspension and Primer	Clinical Diagnostic Solutions, Inc.	KRX	Class II	1999-12-20
K993371	Saddle Shaped Patella	Wrightmedicaltechnologyinc	JWH	Class II	1999-12-20
K993289	Smith & Nephew Compression Hip Screw System, Intramedullary Hip Screw System	Smith & Nephew, Inc.	KTT	Class II	1999-12-20
K993169	Modification of: Physiological Signal Transmitter and Receiver, Model 3810A	Hewlett-Packard Co.	DRG	Class II	1999-12-20
K993096	Privalink Software Accessory to the Lifestream Cholesterol Monitor	Lifestream Technologies, Inc.	CHH	Class I	1999-12-20
K993048	Roche Diagnostics Influenza A/b Rapid Test	Roche Diagnostics GmbH	PSZ	Class II	1999-12-20
K992635	Interface Module Iddd	Stoeckert Instrumente	KRI	Class I	1999-12-20
K992531	Ultegra System Analyzer, Ultegra System Rpfa-Trap Test Cartidges, Ultegra System Rpfa-Trap Level One Qc, Ultegra System	Accumetrics, Inc.	JOZ	Class II	1999-12-20
K992355	Lactosorb Trauma Plating System	Zimmer GmbH	HRS	Class II	1999-12-20
K992121	Embolization Coil System	Cook Inc.	KRD	Class II	1999-12-20
K991964	Eis Threaded Screw Fracture Fixation	Groupe Lepine	HWC	Class II	1999-12-20
K991835	Hang Ups Power II	Stl Intl., Inc.	ITH	Class II	1999-12-20
K991439	Poller Calibrants	European Concerted Action on Anticoagulation	GGN	Class II	1999-12-20
K990849	Duration IV Sterilization Process (Acetabular Inserts)	Howmedica Osteonics Corp	LPH	Class II	1999-12-20
K982100	Igg and Igg Subclass Nephelometric Diagnostic Test Kits	The Binding Site	CFN	Class II	1999-12-20
K981915	Turbidimetric/nephelometric Human Complememt Reference Preparation	The Binding Site	JJY	Class I	1999-12-20
K981785	C4 Minineph Antiserum	The Binding Site	DBI	Class II	1999-12-20
K981783	C3 Minineph Antiserum	The Binding Site	CZW	Class II	1999-12-20
K994010	Innovaquartz General Shape Laser Fiber	Innovaquartz LLC	GEX	Class II	1999-12-17
K993967	Oratec Spinecath Intradiscal Catheter, Model 920002	Oratec Interventions, Inc.	GEI	Class II	1999-12-17