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 2026-10-19, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 3051 of 3529

510(k) clearances, page 3051 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K842267	C-Pep-Ria-100	Institut National des Radioelements	JKD	Class I	1984-09-06
K841736	Il Test Antithrombin III Activity	Instrumentation Laboratory Co.	JBQ	Class II	1984-09-06
K833171	Monitoring Kit	Transamerica Delaval, Inc.	DRS	Class II	1984-09-06
K843389	Clinitron Air Fluidized Support J-101Ud	Uhi Corp.	INX	Class II	1984-09-05
K843192	Apr Mobile	Philips North America LLC	IZL	Class II	1984-09-05
K843083	Cormed Huber Point Needle	Cormed, Inc., Sub. C.R.Bard, Inc.	GAA	Class I	1984-09-05
K843075	Utility Scissors Disposable Items	Greene International Corp.	JOK	Class I	1984-09-05
K843067	Tca Hearing Aid	Telex Communications, Inc.	ESD	Class I	1984-09-05
K843037	Disposable Laparotomy Sponge	Anago, Inc.			1984-09-05
K842980	In-the-Ear-Canal Hearing Aid	Ear Care Hearing Systems, Inc.	ESD	Class I	1984-09-05
K842949	Amerlex-M Free T-3 Ria	Amersham Corp.	CDP	Class II	1984-09-05
K842907	Calcitonin Radioimmunoassay Kit	Nichols Institute Diagnostics	JKR	Class II	1984-09-05
K842816	Emit D.a.u. Low & Med. Calibrators B	Syva Co.	DKB	Class II	1984-09-05
K842692	Quidel Beta Hcg Enzyme Immunoassay Kit	Ortho-Clinical Diagnostics, Inc.	JHI	Class II	1984-09-05
K842603	Omed Dispos. Instrument Guards	Omega-Med Intl., Inc.			1984-09-05
K842546	Custom Canal Hearing Aid X-Cite 84	Bernafon LLC	ESD	Class I	1984-09-05
K842527	Amizyme-Schistosoma Spp. Test Kit	Amico Lab, Inc.	GNH	Class I	1984-09-05
K842173	Disposable Stopcocks	Procedure Products, Inc.	FMG	Class II	1984-09-05
K842137	Occult Blood Test	Breit Laboratories, Inc.	KHE	Class II	1984-09-05
K842107	Combo Skin Test Ready to Use Tape	Combion Systems, Inc.	SCL	Class II	1984-09-05
K841949	Dose Release of Sterilization Lots	Medcare Disp Products, Inc.	FMF	Class II	1984-09-05
K841852	Autolyzer 800	Geometric Data, Div. Smithkline Corp.	GKZ	Class II	1984-09-05
K840527	Colotrak Occult Blood Test	Breit Laboratories, Inc.	KHE	Class II	1984-09-05
K834558	Ck10000 Series Pouch & Bags Etc.	Currie Medical Specialties, Inc.	KCT	Class II	1984-09-05
K833999	Combion Skin Test - Four Prong	Nicholas H. Maganias	SCL	Class II	1984-09-05
K843440	Mingo Log 7	Siemens Elema AB	DJH	Class II	1984-09-04
K843230	Ventrezyme Pap Kit Immunoassay Prostatic	Ventrex Laboratories, Inc.	JFH	Class II	1984-09-04
K843228	Nd. Yag Laser for Endobronchial Obstruc	Endo Lase, Inc.			1984-09-04
K843141	Critikon Heparin-Coated Cardiovascular	Critikon Company, LLC	LDF	Class II	1984-09-04
K843110	Roche Standards for Cholesterol	Roche Diagnostic Systems, Inc.	JIS	Class II	1984-09-04
K843032	Bilirubin Assay Kit - Total	Diagnostic Chemicals, Ltd. (USA)	CIG	Class II	1984-09-04
K843027	Bilirubin Assay Kit Direct	Diagnostic Chemicals, Ltd. (USA)	CIG	Class II	1984-09-04
K843008	Ion Selective Electrodes & Reagent Sys	American Monitor Corp.	CEM	Class II	1984-09-04
K842954	Cardionostics Holter Dura-Lite Recorde	Cardionostics, Inc.	DSH	Class II	1984-09-04
K842948	Amerlex-M Tsh Ria	Amersham Corp.	JLW	Class II	1984-09-04
K842890	Percufix Catheter Cuff	Medi-Tech, Inc.	KOD	Class II	1984-09-04
K842773	Labsystems Fp-901 Chemistry Analyzer	Labsystems, Inc.	JJE	Class I	1984-09-04
K842680	Ace Universal Tong	Buckman Co., Inc.	HAX	Class II	1984-09-04
K842615	Clark Precision Block Cutter, Cooling	Clark Research and Development, Inc.	IXI	Class II	1984-09-04
K842445	Lh Ria	Syncor Intl. Corp.	CEP	Class I	1984-09-04
K842401	Chemistry Console	Biovation, Inc.	JQP	Class I	1984-09-04
K841997	CT 9800	General Electric Co.	JAK	Class II	1984-09-04
K841641	Corning Magic Cortisol Radioimmuno	Corning Medical & Scientific	CGR	Class II	1984-09-04
K831697	Telectronics Model 2401	Seamed Corp.	DTC	Class II	1984-09-04
K842483	Santa Barbara Medco-Lantophoretic Applic	Santa Barbara Medco, Inc.	EGJ	Class II	1984-08-31
K842860	American Pharmaseal i.v. Start Kit	American Pharmaseal Div. Ahsc			1984-08-30
K842334	Life Monitor I	St. Croix Medical Systems, Inc.	CCK	Class II	1984-08-30
K841893	Maxaman	Cryo2 Corp.	BTL	Class II	1984-08-30
K841795	UV 8001K, Puva 800, Puva 180/200 1000	Waldmann Lighting	KGL	Class II	1984-08-30
K841561	Hesung's Blood Donor Sets	Amkor Trading Co.	BRZ	Class II	1984-08-30