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 2026-10-22, 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 2918 of 3529

510(k) clearances, page 2918 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K860119	Gdc 1742 (a Casting Alloy for Dental Restorations)	Deringer-Ney, Inc.	EJS	Class II	1986-03-17
K860054	Tsh-Irma Coat-a-Count Kit	Siemens Healthcare Diagnostics Inc.	JLW	Class II	1986-03-17
K860035	Model 353C Hearing Aid	Telex Communications, Inc.	ESD	Class I	1986-03-17
K860003	Leeco Testosterone Diagnostic Kit	Leeco Diagnostics, Inc.	CDZ	Class I	1986-03-17
K855147	Medtronic Models 8316,8317,8318 Pulse Generators	Medtronic, Inc.	DXY	Class III	1986-03-17
K855036	Chemistry Control N & a	Integrated Medical Systems Int'L., Inc.	JJY	Class I	1986-03-17
K855035	Calibration Reference I & II	Integrated Medical Systems Int'L., Inc.	JJY	Class I	1986-03-17
K854876	Aldosterone Direct Ria Kit	Biotecx Laboratories, Inc.	KQN	Class II	1986-03-17
K854725	Hurwitz Amniocentesis Needle	BD Becton Dickinson Vacutainer Systems Preanalytic	HIO	Class I	1986-03-17
K854118	Dacomed Corp. Eska-Herrman Voice Prosthesis	Dacomed Corp.	EWL	Class II	1986-03-17
K854106	Baysilex	Cutter Laboratories, Inc.	ELW	Class II	1986-03-17
K853529	Impregum-F	Espe GmbH (US)	ELW	Class II	1986-03-17
K850960	Non-Absorbent Drapes & Absorbent Towels	Excel Health Care Products	KKX	Class II	1986-03-15
K860861	Mcbride Listeria Agar	Gibco Laboratories Life Technologies, Inc.	JSJ	Class I	1986-03-14
K860740	Erika Arterial Line 03-9625-9	National Medical Care, Medical Products Div., Inc.	FJK	Class II	1986-03-14
K860662	Amresco Flow Pac Chloride Reagent No. 2256 & 2271	Amresco, Inc.	CHJ	Class II	1986-03-14
K860661	Amresco Flow Pac Albumin Bromocresol Green Reagent	Amresco, Inc.	CIX	Class II	1986-03-14
K860660	Amresco Flow Pac Carbon Dioxide (CO2) Reagents	Amresco, Inc.	CHS	Class II	1986-03-14
K860654	M.c.r. Knee Prosthesis (Series 3000)	Osteonics Corp.	JWH	Class II	1986-03-14
K860635	Opti-Fix Total Hip System	Richards Medical Co., Inc.	LPH	Class II	1986-03-14
K860628	Inorganic Phosphorus Reagent Set	Sterling Diagnostics, Inc.	CEO	Class I	1986-03-14
K860594	Synatomic Revision Femoral Prosthesis	Depuy, Inc.	JWH	Class II	1986-03-14
K860559	Androstenedione 125I Kit by Ria	Immuchem Corp.	CIZ	Class I	1986-03-14
K860554	Serum Lipase Reagent Set (Turbidimetric)	Sterling Diagnostics, Inc.	CFG	Class I	1986-03-14
K860496	Model Ny-110 for Upper & Lower (Gu) & Pulmonary	Xanar, Inc.	LNK	Class II	1986-03-14
K860478	Serum Iron & Iron Binding Reagent Set	Sterling Diagnostics, Inc.	JIY	Class I	1986-03-14
K860253	Amerlex-M Camp(125)assay System Rpa.508 (100 Kit)	Amersham Corp.	CHO	Class II	1986-03-14
K860245	Enzymatic Alpha-Amylase Reagent Kit	Bio-Analytics Laboratories, Inc.	JFJ	Class II	1986-03-14
K860026	Ultramax III, Dialyzer Reprocessing Device	Medicorp, Inc.	LIF	Class II	1986-03-14
K855214	Cat-3 Catecholamine Assay Kit	Whale Scientific, Inc.	CHQ	Class I	1986-03-14
K855091	Chem-Pro 1000 Clinical Chemistry-Analysis Sys	Sen Tech Medical Corp.	CDS	Class II	1986-03-14
K855042	Km-3 Acetabular Component	Kirschner Medical Corp.	JDL	Class III	1986-03-14
K855014	Quantimetric Plus Calibrator/control Set a	Kallestad Laboratories, Inc.	JIX	Class II	1986-03-14
K854908	Uroflex	Angiomed U.S., Inc.	FAD	Class II	1986-03-14
K854740	Primaderm	Absorbent Cotton Co., Inc.	NAD	Class I	1986-03-14
K854643	Solar	Alpine Dental Equipment Co.	EIA	Class I	1986-03-14
K854642	Solar Cart	Alpine Dental Equipment Co.	EIA	Class I	1986-03-14
K854461	Handi-Move	T.F. Herceg, Inc.	ILK	Class II	1986-03-14
K851243	Greco-Harvey Surfact Bond Cath Hyperalimentation	Cook, Inc.	LJS	Class II	1986-03-14
K860845	Respironics Secureasy	Respironics, Inc.	CBH	Class I	1986-03-13
K860808	Continucath	Orange Medical Instruments, Inc.	CCE	Class II	1986-03-13
K860797	Medical X-Ray Film	India-America Trading Co.	IWZ	Class I	1986-03-13
K860691	Kodak Ektascan Video Camera & Compact Video Camera	Eastman Kodak Company	LMC	Class II	1986-03-13
K860683	Medcare Emergency Shears/punch & Fin Tips	Medcomp Technologies, Inc.			1986-03-13
K860600	Single/multiple Component Metallic Bone Fixation	3M Company	HRS	Class II	1986-03-13
K860587	Kotex Overnite	Kimberly-Clark Corporation	HHD	Class I	1986-03-13
K860503	The Porex Retractor Table	Porex Medical	FSE	Class I	1986-03-13
K860294	Hospital Tabbed Napkins Super Belted Feminine Napk	I.C.D. Industries, Inc.	HHD	Class I	1986-03-13
K855211	Panavia Ex, a Dental Adhesive	Kuraray Co.	EMA	Class II	1986-03-13
K855166	Thackray Total Condylar Knees	Thackray USA	JWH	Class II	1986-03-13