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 2026-11-05, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,132 of the 176,529 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	2,732

176,529 records, page 1495 of 3531

510(k) clearances, page 1495 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K023699	Clearblue Easy Early Result Pregnancy Test	Unipath, Ltd.	LCX	Class II	2002-11-27
K023647	Cadence Peek Cemeent Restrictor	Spinal Concepts, Inc.	JDK	Class II	2002-11-27
K023641	Datex-Ohmeda Hmef Mini	GE Healthcare	CAH	Class II	2002-11-27
K023604	Modification to Radial Head Implant	Avanta Orthopaedics, Inc.	KWI	Class II	2002-11-27
K023306	Mirage Full Face Mask Series 2	ResMed Corp	BZD	Class II	2002-11-27
K023284	Mirage Full Face Mask Series 2	ResMed Corp	BZD	Class II	2002-11-27
K023244	Mirage Full Face Mask Series 2	ResMed Corp	BZD	Class II	2002-11-27
K022977	Stratus Cs D-Dimer Calpak Calibrator, Model Cddmr-C	Siemens Healthcare Diagnostics Inc.	DAP	Class II	2002-11-27
K022918	Adapters with X-Coating	Terumo Cardiovascular Systems Corporation	DTL	Class II	2002-11-27
K022903	Chillbuster	Microtek Medical LLC	DWJ	Class II	2002-11-27
K022329	Ca 125 II Assay for the Bayer Advia Integrated Module System	Bayer Diagnostics Corp.	LTK	Class II	2002-11-27
K022236	Recovery Filter System, Model RF-048F	C.R. Bard Inc	DTK	Class II	2002-11-27
K021363	Endovascular Guide Wire	Stereotaxis Inc	DQX	Class II	2002-11-27
K023816	Canon Full Auto Tonometer Tx-F	Canon, Inc.-Utsunomiya Optical Products Operation	HKX	Class II	2002-11-26
K023681	Renegade Stc 18 Microcatheter	Boston Scientific Corporation	DQO	Class II	2002-11-26
K023675	Synthes Cervifix/ Axon	Synthes (USA) Products LLC	KWP	Class II	2002-11-26
K023530	Horizon 38 (Clear) and Horizon 38 Westint (Tinted)	Westcon Contact Lens Co., Inc.	LPL	Class II	2002-11-26
K023479	Femtex Tampons and Other Private Label Plastic Applicator Tampons; Consumer Packages and Bulk Packages	First Quality Hygienic, Inc.	HEB	Class II	2002-11-26
K023390	My Breast Friend, Breast Self-Exam Pad	Mbf Sales, LLC	IXH	Class I	2002-11-26
K023178	Innova 4100	GE Healthcare	OWB	Class II	2002-11-26
K023056	Circuit Tubings with X-Coating	Terumo Cardiovascular Systems Corporation	DWF	Class II	2002-11-26
K023033	Allgrad Wash (Herpes Buffered Washing Medium)	<Genx> Intl., Inc.	MQL	Class II	2002-11-26
K022887	Interphalangeal Flexible Stabilizing Rod System	Osteomed	KWH	Class II	2002-11-26
K022861	Safetouch	Rusin Medical Devices	NHM	Class II	2002-11-26
K021897	Randox Haemoglobin A1c	Randox Laboratories, Limited	LCP	Class II	2002-11-26
K013072	Chronos Tricalcium Prosphate (Chronos Tcp)	Synthes GmbH	MQV	Class II	2002-11-26
K023768	Ecat Pet/ct; Ecat Lso Pet/ct; Ecat Lso Pet/ct 16	Siemens Medical Solutions USA, Inc.	KPS	Class II	2002-11-25
K023671	Aqueous Acrylic Dispersion 28% W/w	CHX Technologies Inc.	LBH	Class II	2002-11-25
K023644	Modification to Incompass Spinal Fixation System	Spinal Concepts, Inc.	MNI	Class II	2002-11-25
K023331	Bd Vacutainer Sst II Plus Tubes	Becton Dickinson & Co	JKA	Class II	2002-11-25
K023296	Cobas Integra Online Dat II Cocaine II	Roche Diagnostics GmbH	DIO	Class II	2002-11-25
K023155	Aloclair Oral Rinse	Sinclair Pharmaceuticals Ltd	OLR	Unclassified	2002-11-25
K023093	Access Hypersensitive Htsh Assay	Siemens Healthcare Diagnostics Inc.	JLW	Class II	2002-11-25
K023075	Bd Vacutainer Plus Sst Serum Separator Tube	BD Vacutainer Systems Preanalyical Solutions	JKA	Class II	2002-11-25
K023066	Drill Guide Attachment (Pn 3105 Dg) of the Sodem High Speed System (Pneumatic)	Sodemsystems	HBB	Class II	2002-11-25
K023029	Demetech Silk Nonabsorbable Suture	Demetech Corp.	GAP	Class II	2002-11-25
K022989	Radlite Tissue Retractor System	Genzyme Biosurgery	FSW	Class II	2002-11-25
K022971	Microhybrid 11	Ab Ardent	EBF	Class II	2002-11-25
K022892	Ascension Sillicone Mcp	Ascension Orthopedics, Inc.	KYJ	Class II	2002-11-25
K022886	Metatarsophalangeal Flexible Stabilizing Rod System	Osteomed	KWH	Class II	2002-11-25
K022853	Endotack	Karl Storz Endoscopy-America, Inc.	MBI	Class II	2002-11-25
K022839	Fotona Dualis Plus Nd:yag Laser System	Fotona D.D.	GEX	Class II	2002-11-25
K022838	Fotona Dualis Er:yag/ktp Laser System	Fotona D.D.	GEX	Class II	2002-11-25
K022837	Fotona Tandem Laser System	Fotona D.D.	GEX	Class II	2002-11-25
K022800	Visiquant Anti-Nuclear Antibody Test System	Hyperion, Inc.	DHN	Class II	2002-11-25
K022686	Lap Surgical Systems Multiple Instrument Guide	Lap Surgical Systems, LLC	FED	Class II	2002-11-25
K023772	Kinetdx Picture Archiving and Communications System	Acuson Corp.	LLZ	Class II	2002-11-22
K023760	CT Cardiac Function Analysis Software, Models Cscf-001A and Cscf-001B	Toshiba America Medical Systems, In.C	JAK	Class II	2002-11-22
K023750	Cannon Digital Radiography Model Cxdi-40G	Canon Medical Components U.S.A., Inc.	MQB	Class II	2002-11-22
K023687	Somatom Emotion 6 CT Systems	Siemens Medical Solutions USA, Inc.	JAK	Class II	2002-11-22