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 1519 of 3531

510(k) clearances, page 1519 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K022203	Abbott Lifecare Pca 3 Infuser, Model 12384	Abbott Medical	MEA	Class II	2002-08-01
K022193	Dinamap Procare Series Monitor, Models 100N, 200N, 300N, 400N	GE Medical Systems Information Technologies, Inc.	DQA	Class II	2002-08-01
K022168	Envoy	Mennen Medical, Inc.	DQA	Class II	2002-08-01
K022162	Stryker T4 Urethane Hood; Stryker T4 Urethane Zipper Toga; Stryker T4 Urethane Pullover Toga	Stryker Corp.	FYA	Class II	2002-08-01
K022160	Xia Spinal System	Howmedica Osteonics Corp	MNI	Class II	2002-08-01
K022024	Nitrile Powder-Free Medical Examination Glove (Green)	Best Manufacturing Company	LZA	Class I	2002-08-01
K022019	Perifix Catheter Connector	B.Braun Medical, Inc.	BSO	Class II	2002-08-01
K021995	Escape Control Module	Specialty Drives Technologies, Inc.	ITI	Class II	2002-08-01
K021971	Ceraloy	Neirynck & Vogt NV	EJH	Class II	2002-08-01
K021954	Bd Phoenix Automated Microbiology System-Clindamycin 0.125-8.0Mcg/ml	Becton Dickinson & Co	LON	Class II	2002-08-01
K021950	Top Glove Medical (Thailand) Powdered Latex Examination Gloves	Top Glove Medical (Thailand) Co., Ltd.	LYY	Class I	2002-08-01
K021853	Disposable Vinyl Examination Gloves, Yellow Color, Powder Free with Vitamin E	Shanghai Antares Industries, Inc.	LYZ	Class I	2002-08-01
K021549	Contoured Articular Prosthesis (Cap) Femoral Head Resurfacing System	Std Mfg., Inc.	KXA	Class II	2002-08-01
K021540	Rusch Edgar Tube	Rusch Intl.	BTR	Class II	2002-08-01
K021510	Uni-T Uni-Thread Spinal System	Spine Vision, Inc.	MNI	Class II	2002-08-01
K021507	Plus Pivot Link Universal System	Spine Vision, Inc.	KWP	Class II	2002-08-01
K021503	Uninhibited	Bisco Inc	EBD	Class II	2002-08-01
K021486	Herpeselect 2 Elisa Igg, Model Elo920g	Focus Technologies, Inc.	MXJ	Class II	2002-08-01
K021457	Flex Span Temporary Crown & Bridge Material	Pentron Corp.	EBG	Class II	2002-08-01
K021456	Er150/m2	World of Medicine Lemke GmbH	GCJ	Class II	2002-08-01
K021452	Sterile Sensicare Advantix Powder Free Polyurethane Medical/dental Examination Glove	Maxxim Medical	LZA	Class I	2002-08-01
K021450	Clinpro Prophy Powder	3M Espe AG Dental Products	KOJ	Class II	2002-08-01
K021352	Dayton Water Systems Ultrapure Water Treatment Systems for Hemodialysis	Dayton Water Systems	FIP	Class II	2002-08-01
K021342	Normed Bi-Directional/multidirectional Jaw Distractor	Osteomedics, Inc.	JEY	Class II	2002-08-01
K021341	Normed Bone Transport Distraction Device	Osteomedics, Inc.	JEY	Class II	2002-08-01
K020040	Latex Pre-Powdered Examination Gloves with Protein Claim	P.T. Maja Agung Latexindo	LYY	Class I	2002-08-01
K013093	Pall Ultipor Anesthesia Breathing System	Pall Medical	CAH	Class II	2002-08-01
K012693	Mistral Critical Care Jet Ventilator and Accessories	Acutronic Medical Systems AG	CBK	Class II	2002-08-01
K012687	Vanguard Reprocessed Diagnostic Electrophysiology Catheters	Stryker Sustainability Solutions	NLH	Class II	2002-08-01
K021387	Polar Wand	Chek-Med Systems	GEH	Class II	2002-07-31
K012688	Vanguard Reprocessed Diagnostic Electrophysiology Catheters	Stryker Sustainability Solutions	NLH	Class II	2002-07-31
K022355	Quicktox Multiple Drug Dipcard Coc/met/thc/amp/pcp/bzo/bar/mtd/tca, Model Qt61	Branan Medical Corp.	DIO	Class II	2002-07-30
K022303	Philips M2424 Diagnostic Ultrasound System &Philips 21315 Diagnostic Ultrasound Transducer	Philips North America LLC	IYN	Class II	2002-07-30
K022296	Modification to En-Bloc Biopsy System	Neothermia Corp.	GEI	Class II	2002-07-30
K022141	Verdict-II	MEDTOX Diagnostics, Inc.	DJC	Class II	2002-07-30
K022125	Provox Freehands Hme, Model 7710	Atos Medical AB	EWL	Class II	2002-07-30
K022029	Quincke Spinal Needle	Epimed International, Inc.	BSP	Class II	2002-07-30
K021969	Chroloy	Neirynck & Vogt NV	EJH	Class II	2002-07-30
K021482	Quanta Lite Sla (Soluble Liver Antigen) Elisa	Inova Diagnostics, Inc.	NIY	Class II	2002-07-30
K021442	Oemedic International Inc. Besmed Single Use Adult, Child, Infant Manual Resuscitator with Mask & Reservoir	Oemedic International, Inc.	BTM	Class II	2002-07-30
K021436	Ttech Model 200E + TENS Device	Theratech, Inc.	GZJ	Class II	2002-07-30
K021264	Trz-Cg Power Positioning System with Center-of-Gravity Shifting Power Tilt, Recline, and Power Elevating Seat	Motion Concepts LP	ITI	Class II	2002-07-30
K021231	Nmp22 Bladderchek Kit, Nmp22 Control Kit	Matritech, Inc.	MMW	Class II	2002-07-30
K021041	Wa Rubbermate Latex Powder-Free Exam Gloves	W.A. Rubbermate Co., Ltd.	LYY	Class I	2002-07-30
K020665	Hi-Ox	Sensor Medics Corp.	CBP	Class II	2002-07-30
K020227	Selicor, Models A100 & D100	Selicor, Inc.	IMJ	Class II	2002-07-30
K020042	Hycare Latex Examination Glove, Powder Free	Hycare Intl. Co., Ltd.	LYY	Class I	2002-07-30
K014070	Epoch Hip Prosthesis, Model 4075 Series	Zimmer GmbH	LPH	Class II	2002-07-30
K013763	Wu's 4-Wheeled Neo Scooter, Wt-L4	Wu's Tech Co., Ltd.	INI	Class II	2002-07-30
K013728	Trach Vox	Engineered Medical Systems, LLC	JOH	Class II	2002-07-30