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 2026-10-15, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,969 of the 176,366 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	2,569

176,366 records, page 3099 of 3528

510(k) clearances, page 3099 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K840636	Children's Wheelchairs	Poirier S.A.	IQC	Class II	1984-02-27
K840635	Training Wheelchair	Poirier S.A.	IQC	Class II	1984-02-27
K840634	Olympic & Basket Wheelchairs	Poirier S.A.	IQC	Class II	1984-02-27
K840633	Airport Wheelchair	Poirier S.A.	IOR	Class I	1984-02-27
K840632	Hemiplegic Wheelchair	Poirier S.A.	IQC	Class II	1984-02-27
K840631	Arnas Wheelchair	Poirier S.A.	IQC	Class II	1984-02-27
K840630	Poirier Reglade Wheelchair	Poirier S.A.	IQC	Class II	1984-02-27
K840629	Wheelchair Accessories	Poirier S.A.	KNN	Class I	1984-02-27
K840628	Large Front Wheels Wheelchair	Poirier S.A.	IQC	Class II	1984-02-27
K840627	Amputee Wheelchair	Poirier S.A.	IQC	Class II	1984-02-27
K840626	Verticalibre Wheelchair	Poirier S.A.	IPL	Class II	1984-02-27
K840625	Union Wheelchair	Poirier S.A.	IQC	Class II	1984-02-27
K840624	Combi	Besam, Inc.	ITI	Class II	1984-02-27
K840583	Spottest Voges-Proskauer Reagent B	Difco Laboratories, Inc.	JTO	Class I	1984-02-27
K840582	Spottest Ferric Chloride Reagent	Difco Laboratories, Inc.	JTO	Class I	1984-02-27
K840581	Spottest Nitrate Reagent C	Difco Laboratories, Inc.	JTO	Class I	1984-02-27
K840580	Spottest Nitrate Reagent B	Difco Laboratories, Inc.	JTO	Class I	1984-02-27
K840579	Spottest Nitrate Reagent a	Difco Laboratories, Inc.	JTO	Class I	1984-02-27
K840578	Spottest Voges-Proskauer Reagent a	Difco Laboratories, Inc.	JTO	Class I	1984-02-27
K840577	Spottest Kovacs' Indole Reagent	Difco Laboratories, Inc.	JTO	Class I	1984-02-27
K840576	Spottest Dmaca Indole Reagent	Difco Laboratories, Inc.	JTO	Class I	1984-02-27
K840575	Spottest Oxidase Reagent	Difco Laboratories, Inc.	JTO	Class I	1984-02-27
K840554	Blood Agar W/ampicillin	Remel Co.	JSJ	Class I	1984-02-27
K840520	Mycological Selective Medium	Scientific Device Laboratory, Inc.	JSJ	Class I	1984-02-27
K840519	Dtm Agar	Scientific Device Laboratory, Inc.	JSJ	Class I	1984-02-27
K840392	Novox Oxygen Analyzer 400	Novametrix Medical Systems, Inc.	CCL	Class II	1984-02-27
K840385	Video Print	Advanced Instruments, LLC	LMC	Class II	1984-02-27
K840263	Lifecare 4/Homecare - 4H Pump	Abbott Medical	FRN	Class II	1984-02-27
K840252	Rim Gram Reaction Swab	Austin Biological Laboratories	JTO	Class I	1984-02-27
K840251	Patient Monitor 78534B	Hewlett-Packard Co.	DRT	Class II	1984-02-27
K840234	Poirier Variable Wheelchair	Poirier S.A.	IQC	Class II	1984-02-27
K840202	Epidural Catheter	Aries Medical, Inc.	BSO	Class II	1984-02-27
K840150	Total Hip Femoral Component	Advanced Biosearch Assn.	JDI	Class II	1984-02-27
K840034	Vacuum Stretcher Immobilizer	Medicon Co., Ltd.	FPP	Class I	1984-02-27
K840012	Indirect Fluorescent Antibody Myco	Zeus Technologies	GRZ	Class I	1984-02-27
K834612	Wilcor-Xr Rp-Og Medical Film	Cea America Corp.	IWZ	Class I	1984-02-27
K834584	Nabi Crp-Q.s. Test	Intl. Diagnostic, Inc.	DCN	Class II	1984-02-27
K834560	Vitex P.d.a	Jeneric Ind.	EJH	Class II	1984-02-27
K834521	Discrete Clinical Analyzer	E.I. Dupont de Nemours & Co., Inc.	JJE	Class I	1984-02-27
K834502	Ck-Nac Reagent	Roche Diagnostic Systems, Inc.	CGS	Class II	1984-02-27
K834409	Denture Base Resin	Dentsply Intl.	EBI	Class II	1984-02-27
K834370	Mulhollan Arthroscopic Needle Carrier	Acufex Microsurgical, Inc.	LXH	Class I	1984-02-27
K834369	Crane Meniscal Suture Set	Acufex Microsurgical, Inc.	LXH	Class I	1984-02-27
K834366	Surgical Instruments & Accessories	C.B.S. Biotechnics, Inc.	EMH	Class I	1984-02-27
K834363	Endix Radicular Bioceramic Pin	C.B.S. Biotechnics, Inc.	ELS	Class II	1984-02-27
K834338	Mycoplasma Pneumoniae Cf Antigen	Hillcrest Biologicals	GSB	Class I	1984-02-27
K834254	Pbc IV Set Vented	Philadelphia Biologics Center	FPA	Class II	1984-02-27
K834253	Pbc IV Set Non-Vented	Philadelphia Biologics Center	FPA	Class II	1984-02-27
K834252	Pbc Extension Set	Philadelphia Biologics Center	FPA	Class II	1984-02-27
K834224	Vacuum Regulator 0-2000 Mmhg Vr-1000	Trimeter Instrument Corp.	KDP	Class II	1984-02-27