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 2026-10-29, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 2550 of 3530

510(k) clearances, page 2550 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K901035	Fiber Optic Light Guide or Fiber Optic Cable	Cuda Products Co.	FST	Class II	1990-04-23
K900926	Trochanter Cable Grip System (Add'l Indications)	Howmedica Corp.	LRN	Class II	1990-04-23
K900854	John Bunn: Medix Compact Traveller	The John Bunn Co.	BTT	Class II	1990-04-23
K900671	Hare Emergency Stretcher with Wheels	Dyna Corp.	FPP	Class I	1990-04-23
K900670	Hare Emergency Stretcher	Dyna Corp.	FPP	Class I	1990-04-23
K900602	Devilbiss Ap-50 Compressor/nebulizer	Devilbiss Health Care, Inc.	BTT	Class II	1990-04-23
K900548	Shiley Phonation Valve	Shiley, Inc.	BTO	Class II	1990-04-23
K900148	Kit Pak Irrigation Tray	Kit Pak, Inc.	EYN	Class II	1990-04-23
K900047	Thayer Suction Evacuation Condensate Collection	Thayer Medical Corportation	BYH	Class I	1990-04-23
K897168	Epicutaneo-Cava Catheter Code 2184	Vygon Corp.	LJS	Class II	1990-04-23
K897102	Hydrasorb(tm)	Avitar, Inc.	JOH	Class II	1990-04-23
K897089	Wee-Peepers (Cushioned Children's Sunshades)	Inno-Lite Co., Inc.	HQZ	Class I	1990-04-23
K896887	Trachael Suction Set	Orion Life Systems, Inc.	BSY	Class I	1990-04-23
K896799	Paracervical/pudendal Trays	Westmark, Sterile Packing Systems, Inc. (Sps)	CAZ	Class II	1990-04-23
K896341	Fluroshield(tm) Visible Light Cure Pit & Fissure	Dentsply Intl.	EBC	Class II	1990-04-23
K896038	B-Scan 10 Mhz Probe	Teknar, Inc.	ITX	Class II	1990-04-23
K895775	Cf Indicator Model 9800 Sweat Test System	Medtronic, Inc.	KTB	Class II	1990-04-23
K895180	Usci 7F Large Lumen Guiding Catheter	C.R. Bard Inc	DQO	Class II	1990-04-23
K901708	Fortress Commuter Rt (Rigid Transport)	Fortress, Inc.	ITI	Class II	1990-04-20
K901608	Hpi Powder Free Non-Sterile Examination Gloves	Hpi, Inc.	LYY	Class I	1990-04-20
K901526	Pro Treatment Table	R&R Ent., Inc.	JFB	Class II	1990-04-20
K900995	Emit D.a.u. Amphetamine Class Assay	Syva Co.	DKZ	Class II	1990-04-20
K900707	Modified Accufluor Tobramycin Reagent & Calibrator	Innotron of Oregon, Inc.	LFW	Class II	1990-04-20
K900640	Modified Mp-4 Cardioplegia Delivery System W/condu	3M Company	DTR	Class II	1990-04-20
K900627	Model 5866-34 Lead Adaptor Kit	Medtronic, Inc.	DTD	Class II	1990-04-20
K900550	Fast-Pass Ace Models 1212T/1222t/1216t/1226t	Pacesetter Systems	DTB	Class III	1990-04-20
K900486	Appose Unity Sterile Disposable Skin Stapler	Davis & Geck, Inc.	GDT	Class I	1990-04-20
K900374	Adair/veress Needle Introducer Set	Medical Dynamics, Inc.	GCB	Class I	1990-04-20
K900306	Hemodialysis Blood Lines	Gainor Medical Europe, Ltd.	KOC	Class II	1990-04-20
K900305	Intravascular Imaging Systems	Intertherapy, Inc.	LYK	Class II	1990-04-20
K896700	Type 9140/Neo	S & W Medico Teknik	DRT	Class II	1990-04-20
K896699	Type 9040/Neo	S & W Medico Teknik	DRT	Class II	1990-04-20
K894703	Simon Nitinol Filter	Nitinol Medical Technologies, Inc.	DTK	Class II	1990-04-20
K894664	Capiox Hardshell Venous Reservoir	Terumo Medical Corp.	DTN	Class II	1990-04-20
K893981	Watchchild	Monox, Inc.	HGM	Class II	1990-04-20
K901578	Coat-a-Count Prolactin Irma #:Ikpr1, Ikpr2	Siemens Healthcare Diagnostics Inc.	CFT	Class I	1990-04-19
K901375	Grasp (Grigg-Russel Air Support Pillow)	Medical Plastics Laboratory, Inc.	INW	Class I	1990-04-19
K901226	Chem 1 Clinical Analyzer (Method Urine Calcium)	Technicon Instruments Corp.	CIC	Class II	1990-04-19
K901158	Litebox Diagnostic Review Workstation	Siemens Gammasonics, Inc.	LLZ	Class II	1990-04-19
K901153	Sony Vo-5800H Videocassette Recorder	Sony Medical Electronics Co.	JAA	Class II	1990-04-19
K901115	Multiconstituent Serum Range Linearity #88234	Hichem Diagnostics	JJY	Class I	1990-04-19
K901050	No-Stick Composite Instrument Dip	Pulpdent Corporation	EBD	Class II	1990-04-19
K901038	Sps 550-Ips (Integrated Patient Station)	Baxter Healthcare Corporation	FIL	Class II	1990-04-19
K901034	Models Wep-8410A and Wep-8420A Telemetry Central	Nihon Kohden America Inc	DRT	Class II	1990-04-19
K900990	Filt-R-All Bacterial/viral Filter	Inhalation Plastics, Inc.	CAH	Class II	1990-04-19
K900982	E-Clip	Joel Cohen & Esther R. Cohen	LDF	Class II	1990-04-19
K900938	Manual Wheelchair	Advanced Mobility Systems Corp.	IOR	Class I	1990-04-19
K900898	9000 Economical 14 X 17 Video Imager	International Imaging Electronics	LMC	Class II	1990-04-19
K900897	5000/5000C Multi-Format Cameras for Nuclear Medi.	International Imaging Electronics	LMC	Class II	1990-04-19
K900893	Cardiovue Cfs-100	Bv Medical Equipment Co.	JAA	Class II	1990-04-19