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 2346 of 3531

510(k) clearances, page 2346 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K921475	A-Port Implant Vascular Access Syst Cath - 75Cm	Therex Corp.	LJT	Class II	1992-10-16
K920824	Roadrunner Rltf Guide Wire	Cook Inc.	DQX	Class II	1992-10-16
K920668	Minutex D-Dimer Latex Test	Biopool AB	GHH	Class II	1992-10-16
K915287	Isol-Aide	Computronic Systems	CBN	Class II	1992-10-16
K924599	Creatinine-Ip Test, # 42375/93, 42323/R1, 42323/R2	Em Diagnostic Systems, Inc.	CGX	Class II	1992-10-15
K924446	Micro-Plate Opiates Assay	Solarcare Technologies Corp,Inc.	DJG	Class II	1992-10-15
K924429	Opus(r) Ck-Mb	Pb Diagnostic Systems, Inc.	JHY	Class II	1992-10-15
K923935	Sd-605 Sd II Program	Skylark Device Co., Ltd.	GZJ	Class II	1992-10-15
K923839	Nitinol Gentle Touch Coil Spring	Ultimate Wireforms, Inc.	DZC	Class I	1992-10-15
K923683	Cynosure Photogenica T Tattoo Removal Laser	Cynosure, LLC	GEX	Class II	1992-10-15
K923596	Heart Nebulizer	Vortran Medical Technology 1, Inc	CAF	Class II	1992-10-15
K923571	Vista Triiodothyronine Assay	Syva Co.	CDP	Class II	1992-10-15
K923511	Ck-Nac Activated Kit	Randox Laboratories, Limited	CGS	Class II	1992-10-15
K923385	Boston Brand Hypoallergenic Latex Gloves	Boston Medical Corp.	LYY	Class I	1992-10-15
K923099	X-Ray Drapes	Hydro-Med Products, Inc.	IWQ	Class I	1992-10-15
K922421	Kinamed Ath-Porous and Ath-Porous Long Total Hip	Kinamed Inc	JDI	Class II	1992-10-15
K921875	X-Ray Control and Hi-Voltage Generator	Continental X-Ray Corp.	IZO	Class I	1992-10-15
K921823	Arthrex Arthroscopy Ice Blade	Arthrex GmbH	HRX	Class II	1992-10-15
K921803	Sofnolime Carbon Dioxide Absorbent	Molecular Products Inc	CBL	Class I	1992-10-15
K920145	Biopro Drg Custom Hip Replacement System	Biopro, Inc.	LZO	Class II	1992-10-15
K915415	Guardall Shield	Anago, Inc.	LYU	Class I	1992-10-15
K914748	Comet C-125	Fischer Imaging Corp.	OXO	Class II	1992-10-15
K911973	Linear Accelerator Collimator	Medical Equipment Development Co., Inc.	IYE	Class II	1992-10-15
K924470	Two Part Inorganic Phosphorus Test	Em Diagnostic Systems, Inc.	CEO	Class I	1992-10-14
K923598	Redi-Check Photmeter Q.a.	Awareness Technology, Inc.	JFS	Class II	1992-10-14
K923582	Sienet Camera Server	Siemens Gammasonics, Inc.	LMD	Class I	1992-10-14
K923530	Coulter Multi-Q-Prep	Coulter Electronics, Inc.	GKH	Class I	1992-10-14
K923048	Accu-Chek Easy Blood Glucose System	Boehringer Mannheim Corp.	CGA	Class II	1992-10-14
K922945	Technicon Dax System Thyroxine (T4) Method	Kulzer GmbH	CDX	Class II	1992-10-14
K922771	Kodak Amerlex Mab Ft3 Assay	Eastman Kodak Company	CDP	Class II	1992-10-14
K922768	Rapid Nft, Modification	Biomerieux Vitek, Inc.	JSW	Class I	1992-10-14
K922117	C-Trak Biopsy System	Care Wise Medical Products Corp.	IZD	Class I	1992-10-14
K921526	Datascope Passport Monitor with CO2	Datascope Corp.	CCK	Class II	1992-10-14
K920984	King of Hearts Express (E.x.) Monitor	Instromedix, Inc.	DXH	Class II	1992-10-14
K920506	Contouring Device	X-Icon Medical Systems	KPQ	Class II	1992-10-14
K920196	Ox-600	Stardard X-Ray Sales Co.	KPX	Class II	1992-10-14
K913711	Gentle Slope	Octostop, Inc.	KPR	Class II	1992-10-14
K913659	Little Prism	Octostop, Inc.	KPR	Class II	1992-10-14
K904211	Bioself 2000 Fertility Indicator	Bioself, Inc.	LHD	Unclassified	1992-10-14
K924704	Creatine Kinase (Ck) Test Item #65411	Em Diagnostic Systems, Inc.	CGS	Class II	1992-10-13
K924514	Acufex Fixation Post	Acufex Microsurgical, Inc.	HWC	Class II	1992-10-13
K924475	Accudata Glucose Test Station	Boehringer Mannheim Corp.	CGA	Class II	1992-10-13
K923671	Cox Disposable Polypectomy Snares	Cox Medical Ent., Inc.	FDI	Class II	1992-10-13
K923633	Multiqual Assay Products	Ciba Corning Diagnostics Corp.	JJY	Class I	1992-10-13
K923632	Multiqual Unassayed Products	Ciba Corning Diagnostics Corp.	JJY	Class I	1992-10-13
K923472	Compacolor	Wilde-USA, Inc.	EBF	Class II	1992-10-13
K923456	Microlite Microtiter Plate Luminometer Ml3000	Dynatech Laboratories, Inc.	JJQ	Class I	1992-10-13
K923415	Dba Focal Change Frames	Focal Change	HQZ	Class I	1992-10-13
K923332	Electrosurgical Electrodes	Premier Dental Products Co	GEI	Class II	1992-10-13
K923298	Micro 100,200,300, & 400 TENS	Skylark Device Co., Ltd.	GZJ	Class II	1992-10-13