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 2975 of 3529

510(k) clearances, page 2975 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K852516	Centifuge, Hematocrit & Microsedimentation Combine	Whittaker General Medical	JPI	Class II	1985-07-15
K852482	Microspin Minicentrifuge Item No. 65204/94	Em Diagnostic Systems, Inc.	JPI	Class II	1985-07-15
K852418	Qcm-Sp1(normal Concenttration) & Sp2(abnormal)	Amf Biological and Diagnostics Co.	JJY	Class I	1985-07-15
K852316	#3011 Pediatric Non-Conduct Anes Cir W/ Brea Bag	Sigma Medical, Inc.	CAI	Class I	1985-07-15
K852315	#3012 Pediatric Non-Conduct Anes Cir W/ Brea Bag	Sigma Medical, Inc.	CAI	Class I	1985-07-15
K852313	#3001 Pediatric Non-Conduct Anes Cir W/ Brea Bag	Sigma Medical, Inc.	CAI	Class I	1985-07-15
K852312	#3005 Pediatric Non-Conduct Anes Cir W/ Brea Bag	Sigma Medical, Inc.	CAI	Class I	1985-07-15
K852311	#3002 Pediatric Non-Conduct Anes Cir W/ Brea Bag	Sigma Medical, Inc.	CAI	Class I	1985-07-15
K852189	Phadebas Rast Test Allergen Discs	Pharmacia, Inc.	DHB	Class II	1985-07-15
K852071	Ohmeda Gms Abosorber	GE Healthcare	BSF	Class I	1985-07-15
K851857	Urological Catheter & Accessories Foley Catheter	Sheridan Catheter Corp.	KOD	Class II	1985-07-15
K851820	Spinal Fluid Control	Irvine Scientific LLC	JJY	Class I	1985-07-15
K851740	Ezzie System	Independent Living, Inc.	IQA	Class II	1985-07-15
K851631	Tmx-C1/c2 Tradmill Controller Access.	Eaton Medical Group	IOL	Class I	1985-07-15
K851541	Dart Immunoglobulins Reagent System	Coulter Electronics, Inc.	DEW	Class II	1985-07-15
K851528	Pasco Gram Negative Identification System	Pasco Laboratories, Inc.	LQM	Class I	1985-07-15
K851509	Ohmeda 7000 Electronic Anesthesia Ventilator	GE Healthcare	CBK	Class II	1985-07-15
K851473	Vygon Delee Suction Catheter Code No 533	Vygon Corp.	BSY	Class I	1985-07-15
K851341	Synatomic Variable Fit Tibial Plateau	Depuy, Inc.	KYK	Class II	1985-07-15
K851134	Regional Anesthesia Trays	Concord Laboratories, Inc.	CAZ	Class II	1985-07-15
K850840	Howmedica Threaded Acetabular Component	Pfizer Inc	KWA	Class III	1985-07-15
K850443	Mec Rod Connector	Pfizer Inc	KTT	Class II	1985-07-15
K850413	Mec Hip Bolt	Pfizer Inc	KTT	Class II	1985-07-15
K850403	Mec Distal Femoral Bolt	Pfizer Inc	KTT	Class II	1985-07-15
K844327	Edentec Model 2000W Apnea Monitor	Edentec Corp.	BZQ	Class II	1985-07-15
K852636	X-Amylase Assay Kit	Diagnostic Chemicals, Ltd. (USA)	CIJ	Class II	1985-07-12
K852603	Mccoy's 5A Medium - Powdered Form	Mediatech, Inc.			1985-07-12
K852602	Mccoy's 5A Medium-Liquid Form	Mediatech, Inc.	KIT	Class I	1985-07-12
K852595	Dc-3 Fluids Pack, Dc-5 Fluids Pack	Diagnostic Chemicals, Ltd. (USA)	JGS	Class II	1985-07-12
K852594	Dc-Lip, Catalogue Number Se-020	Diagnostic Chemicals, Ltd. (USA)	JJY	Class I	1985-07-12
K852583	Data Chem Iron Procedure	Data Medical Associates, Inc.	CFM	Class I	1985-07-12
K852582	Goni-Kit	Culture Kits, Inc.	JSX	Class I	1985-07-12
K852578	Cled Agar	American Laboratory Supply, Inc.	JSH	Class I	1985-07-12
K852573	Technicon Ra-1000 System Analyte Theophylline	Technicon Instruments Corp.	KLS	Class II	1985-07-12
K852568	Mcdb 201 Med Cat No. M6770 W/ Hepes & W0/ Bicarbon	Sigma Chemical Co.	KIT	Class I	1985-07-12
K852565	Technicon Chemi	Technicon Instruments Corp.	CGX	Class II	1985-07-12
K852506	Bioglas Microcarrier Bead	Solohill Engineering, Inc.	KJB	Class I	1985-07-12
K852485	Cellgro(iscove's Medium) Modification	Mediatech, Inc.	KIT	Class I	1985-07-12
K852483	Systemate Ck-Mb(nac-Activated) Item No. 67205	Em Diagnostic Systems, Inc.	CGS	Class II	1985-07-12
K852475	Cellgro Williams' Medium E	Mediatech, Inc.	KIT	Class I	1985-07-12
K852473	Ion-Specific Electrode Option for Cobas Fara	Roche Diagnostic Systems, Inc.	JGS	Class II	1985-07-12
K852461	Chemtrak Liquid Multi-Analyte Calibrator, Mul-Set	Medical Analysis Systems, Inc.	JIT	Class II	1985-07-12
K852438	Nml Tsh Irma	Nuclear Medical Laboratories, Inc.	JLW	Class II	1985-07-12
K852437	Visual Serum/urine Hcg Combo Kit	American Bioclinical, Inc.	JHI	Class II	1985-07-12
K852396	Hek	Viromed Laboratories, Inc.	KIR	Class I	1985-07-12
K852395	Mink Lung	Viromed Laboratories, Inc.	KIR	Class I	1985-07-12
K852394	Mdck	Viromed Laboratories, Inc.	KIR	Class I	1985-07-12
K852385	Hybritech Immunochemistry Analyzer	Hybritech, Inc.	JJF	Class I	1985-07-12
K852374	Oxygen Regulators #50 Prt & Bgt(bgt15,bgt18	The Timeter Group	CAN	Class I	1985-07-12
K852058	Chloride Assay Kit	Diagnostic Chemicals, Ltd. (USA)	CHJ	Class II	1985-07-12