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 2912 of 3529

510(k) clearances, page 2912 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K860765	Emds Chemistry Calibrators, Levels I & II	Em Diagnostic Systems, Inc.	JIX	Class II	1986-04-07
K860764	Emds Enzyme Verifier, Levels I & II	Em Diagnostic Systems, Inc.	JJT	Class I	1986-04-07
K860746	Auto Syringe Micro Vol Ext Set W/air Vent Filter	Travenol Laboratories, S.A.	FPB	Class II	1986-04-07
K860731	Triglycerides Reagent (Int, Colorimetric)	Trace Scientific, Ltd.	JGY	Class I	1986-04-07
K860730	Enzymatic Triglycerides Reagent (Single Vial)	Trace Scientific, Ltd.	CDT	Class I	1986-04-07
K860729	Ldh-P (Lactic Dehydrogenase) Reagent	Trace Scientific, Ltd.	CFJ	Class II	1986-04-07
K860728	L D H-L (Lactic Dehydrogenase) Reagent	Trace Scientific, Ltd.	CFJ	Class II	1986-04-07
K860727	Alt(gpt) (Alanine Aminotransferase) Reagent	Trace Scientific, Ltd.	CKA	Class I	1986-04-07
K860725	Ast(got) (Aspartate Aminotransferase) Reagent	Trace Scientific, Ltd.	CIT	Class II	1986-04-07
K860724	Enzymatic Glucose Reagent (Hexokinase)	Trace Scientific, Ltd.	CFR	Class II	1986-04-07
K860723	G.t. (Gamma-Glutamyl Transferase) Reagent	Trace Scientific, Ltd.	JPZ	Class I	1986-04-07
K860700	Capd Disconnect System 5C4182, 5C4183, 5C4186	Travenol Laboratories, S.A.	KDJ	Class II	1986-04-07
K860675	Companion 2800 Volume Ventilator Remot Alarm	Medtronic, Inc.	CBK	Class II	1986-04-07
K860674	Drs-4 Dialyzer Reprocessing System	Seratronics, Inc.	LIF	Class II	1986-04-07
K860669	Creatine Kinase, N-Acetyl-L-Cystiene	Em Diagnostic Systems, Inc.	CGS	Class II	1986-04-07
K860668	Ion-Specific Electrode, Chloride	Em Diagnostic Systems, Inc.	CGZ	Class II	1986-04-07
K860665	Alpha-Amylase Test	Sclavo, Inc.	JFJ	Class II	1986-04-07
K860595	Transfer Set	Simplivia Healthcare Ltd.	LHI	Class II	1986-04-07
K860589	Inflator/deflator Piston Syringe	Microvasive	KNT	Class II	1986-04-07
K860501	Flame Photometer Standard	Medical Specialties Inc.	JLJ	Class II	1986-04-07
K860366	Challenger Hot Biopsy Forceps	Microvasive	KNS	Class II	1986-04-07
K860357	Hgm, Inc. Lasercath (Sterile)	Hgm, Inc.	LNK	Class II	1986-04-07
K860322	Cliniset Infusion Set	Zimmar Consulting, Ltd.	FPA	Class II	1986-04-07
K860311	Acthk-Pr Ria Kit	Compagnie Oris Industrie, S.A.	CKG	Class II	1986-04-07
K860284	Diamatic, Automatic Insulin Injector	Ulster Scientific, Inc.	KZH	Class II	1986-04-07
K860265	Telescope Protection Tube	R. J. Ltd., Ind.	KOD	Class II	1986-04-07
K860218	Syringe Pump: Vm 07	Vial Medical, Ltd.	FRN	Class II	1986-04-07
K860094	Hurwitz Dialysis Catheter	Gish Biomedical, Inc.	LFJ	Class II	1986-04-07
K860033	Eia Monoclonal Total Ige Kit	Siemens Healthcare Diagnostics Inc.	DGC	Class II	1986-04-07
K860028	Modified Ez Detect Occult Blood Test in Stool	Self Care Systems, Inc.	KHE	Class II	1986-04-07
K855024	Marquest Qc-IV Tonometer	Marquest Medical Products, Inc.	JJS	Class I	1986-04-07
K855002	Kodak Ektascan Image Transmission System	Eastman Kodak Company	LLZ	Class II	1986-04-07
K854598	Vickers Medical Model 272 Temperature Monitor	Vickers, Ltd.	FLL	Class II	1986-04-07
K854308	Polycath-H Catheter	Abbott Medical	FOZ	Class II	1986-04-07
K852616	Mirage Intravenous Infusion Set Olovson-Sterile	Medical Hospital Equipment	FPA	Class II	1986-04-07
K851338	Double Antibody Albumin for Detect Microalbuminuri	Siemens Healthcare Diagnostics Inc.	JIR	Class I	1986-04-07
K861213	Pb 254 Ir - Spectrometer	Datex Division Instrumentarium Corp.	CCK	Class II	1986-04-04
K861066	Ar-1000 Automatic Refractor	Nidek, Inc.	HKO	Class I	1986-04-04
K861063	Nidek Km-800 Auto Keratometer	Nidek, Inc.	HLQ	Class I	1986-04-04
K861062	Ar-1600 Automatic Refractor	Nidek, Inc.	HKO	Class I	1986-04-04
K861028	Superlite Penlight	Keta Corp.			1986-04-04
K861022	Kwik Stik(tm) Lyfo(tm) Disk Microorganisms	Micro-Bio-Logics	JTR	Class I	1986-04-04
K861012	Silent Partner Model 10-1001	Medical Devices Inc.	CAW	Class II	1986-04-04
K861011	Silent Partner Model 10-2001	Medical Devices Inc.	CAW	Class II	1986-04-04
K860979	Donaldson Natural Eyepatch	Keeler Instruments, Inc.	HMP	Class I	1986-04-04
K860967	Virtran Viral Transporter (Modified)	Diagnon Corp.	JSN	Class I	1986-04-04
K860936	Absorbent, Fiber, Operating Room Towels	Ulti-Med Intl., Inc.	KKX	Class II	1986-04-04
K860928	Eyemeter	Indivisual Corporation, Inc.			1986-04-04
K860905	Uricheck	Difco Laboratories, Inc.	JXA	Class I	1986-04-04
K860778	Tandem Icon Strep a Immunoenzymetric Assay Kit	Hybritech, Inc.	GTZ	Class I	1986-04-04