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 2026-10-29, 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 2631 of 3530

510(k) clearances, page 2631 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K893897	Semi-Quantitative Assay for Det. of Igg and Igm	Biostar Medical Products, Inc.	LKJ	Class II	1989-06-23
K893881	Access Tm	Diasonics, Inc.	LNH	Class II	1989-06-23
K893791	Breathing Mouthpiece	Diemolding Corp.	BYP	Class I	1989-06-23
K893787	Lifecell Recovery Container	Baxter Healthcare Corporation	KJF	Class I	1989-06-23
K893784	Acs Human Plasma Coagulation Control Level I	Analytical Control Systems	GIZ	Class II	1989-06-23
K893783	Acs Animal Plasma Coagulation Control Level I	Analytical Control Systems	GIZ	Class II	1989-06-23
K893702	Tecnol Gaiters Product Number 47725-010	Tecnol New Jersey Wound Care, Inc.	FXP	Class I	1989-06-23
K893686	Argeloy N.p.	Argen Precious Metals, Inc.	EJT	Class II	1989-06-23
K893669	Cellmatics Shlamydia Detection System	Difco Laboratories, Inc.	LKH	Class I	1989-06-23
K893654	Memory Chain	American Orthodontics	EJF	Class I	1989-06-23
K893653	Radiographic Ceiling Tube Support Cts15	Fischer Imaging Corp.	IYB	Class I	1989-06-23
K893652	Radiographic Floor Mounted Tubestand Fm 60	Fischer Imaging Corp.	IYB	Class I	1989-06-23
K893650	Platelet Aggregation Profiler Model Pap-4C	Bio/Data Corp.	JPA	Class II	1989-06-23
K893634	Modified Sterilization of Tur Aprons	Brant-Wald Surgicals, Inc.	FXX	Class II	1989-06-23
K893619	Vista Mr 2055 Hp System	Philips North America LLC	LNH	Class II	1989-06-23
K893608	Actichrome Atiii Kit	American Diagnostic Corp.	JBQ	Class II	1989-06-23
K893568	Argenco 56 Type IV Dental Gold Alloy	Argen Precious Metals, Inc.	EJT	Class II	1989-06-23
K893565	Argenco 68 Type IV Dental Gold Alloy	Argen Precious Metals, Inc.	EJT	Class II	1989-06-23
K893549	X-Ring Separators	American Orthodontics	EJF	Class I	1989-06-23
K893542	Diastema Closing Kit	American Orthodontics	EJF	Class I	1989-06-23
K893536	Factor XI Deficient Plasma	Medical Diagnostic Technologies, Inc.	GJT	Class II	1989-06-23
K893535	Factor VII Deficient Plasma	Medical Diagnostic Technologies, Inc.	GJT	Class II	1989-06-23
K893534	Factor XII Deficient Plasma	Medical Diagnostic Technologies, Inc.	GJT	Class II	1989-06-23
K893533	Factor V Deficient Plasma	Medical Diagnostic Technologies, Inc.	GJT	Class II	1989-06-23
K893525	Factor VIII Deficient Plasma	Medical Diagnostic Technologies, Inc.	GJT	Class II	1989-06-23
K893524	Factor IX Deficient Plasma	Medical Diagnostic Technologies, Inc.	GJT	Class II	1989-06-23
K893523	Factor X Deficient Plasma	Medical Diagnostic Technologies, Inc.	GJT	Class II	1989-06-23
K893521	Imlogix 1000 Image Display System	Imlogix A Div. of Microterm	LLZ	Class II	1989-06-23
K893510	Cronex Quanta V Rare Earth Intensifying Screen	E.I. Dupont de Nemours & Co., Inc.	EAM	Class I	1989-06-23
K893480	Byrd Extractor Set	Medical Engineering and Development Institute	GCC	Class I	1989-06-23
K893476	Angiotec Spx Split Screen Dual Channel Scan Conv.	Andros Analyzers, Inc.	JAA	Class II	1989-06-23
K893460	A-Port Implant Vascular Access System .6Mm/2.29mm	Therex Corp.	LJT	Class II	1989-06-23
K893422	Clearview Strep a	Unipath, Ltd.	GTZ	Class I	1989-06-23
K893420	Masterlab Pft and Masterlab Body Box	Quinton, Inc.	CCM	Class II	1989-06-23
K893416	Uric Acid Reagent (Procedure Number 686)	Sigma Chemical Co.	KNK	Class I	1989-06-23
K893402	Compact 2052(Tm) Dual Collection Blood Recovery	Atrium Medical Corporation	CAC	Class II	1989-06-23
K893400	Serumax (Automated Serum Centrifugation & Station)	Medical Robotics	JQW	Class I	1989-06-23
K893396	An Alternative Direct Bonding Ortho. System	American Orthodontics	DYH	Class II	1989-06-23
K893391	Mi-328, Mi-316, Mi-388 Digital Thermometer	Nam Tai Electronic & Electrical Products, Ltd.	FLL	Class II	1989-06-23
K893388	Devilbiss Model 7351D Revitalizer CPAP System	Devilbiss Health Care, Inc.	BYE	Class II	1989-06-23
K893142	Document(tm) Iron, Magnes, Trigly Linear Test Set	Casco Standards	JJY	Class I	1989-06-23
K893141	Document(tm) Iron Magnesium Linearity Test Set	Casco Standards	JJY	Class I	1989-06-23
K893140	Document(tm) Triglyceride Linearity Test Set	Casco Standards	JJX	Class I	1989-06-23
K892942	Breath Tracker	Core-M, Inc.	CAP	Class II	1989-06-23
K892882	Dental Sani-Sleeve Sterile 100Mm X 2200Mm #1102	Nieusma R & D, Inc.	EHZ	Class I	1989-06-23
K892881	Dental Sani-Sleeve Sterile 60Mm X 1650Mm #1101	Nieusma R & D, Inc.	EHZ	Class I	1989-06-23
K892860	Saturne 41	General Electric Co.	IYE	Class II	1989-06-23
K892859	The Stago VIII Deficient Plasma Kit	American Bioproducts Co.	GGP	Class II	1989-06-23
K892691	Catheters, Male, Female	Zinnanti Surgical Instruments, Inc.	KOD	Class II	1989-06-23
K892657	Sensimat	Transworld X-Ray Corp.	IZO	Class I	1989-06-23