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 2048 of 3531

510(k) clearances, page 2048 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K945511	Lifepak 10 Defibrillator/monitor/pacemaker, and Lifepak 11 Cardiac Monitor	Physio Control, Inc.	MPE	Class II	1995-09-26
K944538	Gas Plasma Sterilization	Depuy, Inc.	HRY	Class II	1995-09-26
K943520	Heparin Control Kit	American Bioproducts Co.	KFF	Class II	1995-09-26
K943519	Hbpm/lmwh Control Kit	American Bioproducts Co.	KFF	Class II	1995-09-26
K943514	The Hepanorm Hbpm/lmwh Kit	American Bioproducts Co.	KFF	Class II	1995-09-26
K931609	Chartr Eng System	Ics Medical Corp.	GWM	Class II	1995-09-26
K930191	Danek(tm) Spinal Epidural Endoscopic Sy	Sofamor Danek Mfg., Inc.	HRX	Class II	1995-09-26
K954035	Acti-Flex Arterial Extension Set	R-Group Intl.	CBT	Class I	1995-09-25
K953840	Axsym Phenytoin II	Abbott Medical	LGR	Class II	1995-09-25
K953718	Axsym Digoxin II	Abbott Medical	KXT	Class II	1995-09-25
K953657	Abbott Axsym Prolactin(modification)	Abbott Mfg., Inc.	CFT	Class I	1995-09-25
K953239	Boehringer Mannheim/hitachi 917 Analyzer	Boehringer Mannheim Corp.	JJE	Class I	1995-09-25
K953084	Access Ultrasensitive Insulin Assay	Bio-Rad Laboratories Inc.	CFP	Class I	1995-09-25
K952878	Oxy/star Low Flow Blender	Infrasonics Corp.	BZR	Class II	1995-09-25
K952756	Medi-Aid Basal Thermometer	Polymedica Industries, Inc.	LHD	Unclassified	1995-09-25
K952385	Hema-Trol Q-Check	Medical Specialties Intl., Inc.	JJY	Class I	1995-09-25
K952176	Disposable Neurology Electrodes Neuroline 7 30 01-K	Medicotest, Inc.	GXY	Class II	1995-09-25
K952115	Barrier Gown, Kool-Gard Backless Gown	American Threshold Industries, Inc.	FYC	Class II	1995-09-25
K952114	Kool Gard Singles Gown	American Threshold Industries, Inc.	FYC	Class II	1995-09-25
K951159	Fasguide	Target Therapeutics	DQY	Class II	1995-09-25
K950143	Astral Disposable Skin Temperature Probe	Astral, Ltd.	FMT	Class II	1995-09-25
K946005	Astral Disposable Skin Temperature Probe	Astral, Ltd.	FMT	Class II	1995-09-25
K945207	Mectest	Meco Industries	DIO	Class II	1995-09-25
K945205	Qbc Accutube	Becton Dickinson Diagnostic Instrument Systems	GKZ	Class II	1995-09-25
K944449	Ebv-Vca Igm Elisa Test Ststem	Zeus Scientific LLC	LSE	Class I	1995-09-25
K941752	Spectrolyse Antiplasmin Kit	Biopool AB	GGP	Class II	1995-09-25
K940820	Pershield CPR Device	Rabintex Industries, Ltd.	CBP	Class II	1995-09-25
K935668	Medrad Spectris Mr Injector	Medrad, Inc.	DXT	Class II	1995-09-25
K923691	Twin Silicone Catheter	Medical Components, Inc.	MPB	Class II	1995-09-25
K954231	Augastroenterology-Urology Biopsy Instrument	Promex, Inc.	FCG	Class II	1995-09-22
K954088	Telescoping Penevac	I.C. Medical, Inc.	GEI	Class II	1995-09-22
K954033	Tecnol Island Wound Dressing	Tecnol Medical Products, Inc.	MGP	Unclassified	1995-09-22
K953669	Perspectives Impregnated Hydrogel Wound Dressing	Marketing Perspectives	MGQ	Unclassified	1995-09-22
K953654	Ors-111	O.R. Solutions, Inc.	KKX	Class II	1995-09-22
K953645	Olympic Pasteurmatic System	Olympic Medical Corp.	LDS	Class II	1995-09-22
K953476	Multi-Prime Aka/mono-Prime	Silicon-Und Composite Spezialitaten GmbH	KLE	Class II	1995-09-22
K953163	Quick Read 2000 (Qr2000)	Quicksilver Systems, Inc.	LMD	Class I	1995-09-22
K953138	Medi-Plus, Health Plus, Sanitex, Reliance	Pwa Industries Sdn. Bhd.	LYY	Class I	1995-09-22
K953086	Woodbine/solos, High Resolution 3-Chip Surgical Camera	Woodbine Optical Corp.	GCJ	Class II	1995-09-22
K953082	Iliac Crest Bone Marrow Aspiration Needle	Baxter Healthcare Corporation	GDM	Class I	1995-09-22
K953046	Peri-Pusher	Diacor, Inc.	IYE	Class II	1995-09-22
K952965	The Tulip J Dissector	The Tulip Mfg. Co.	GCJ	Class II	1995-09-22
K952835	Welch Allyn Video Episcope	Welch Allyn Inc	KZF	Class I	1995-09-22
K952159	Basis Digital Thermometer	Polymedica Industries, Inc.	FLL	Class II	1995-09-22
K951980	Collapsible Hypodermic Syringe	Roman Vladimirsky	FMF	Class II	1995-09-22
K950531	Egnell Elite	Hollister, Inc.	HGX	Class II	1995-09-22
K950276	Microsound 6.6F Diagnostic Imaging Catheter Model 50302, Intravascular Ultrasound Imaging System	Endosonics Corp.	IYO	Class II	1995-09-22
K946376	Maxx	Mayer Laboratories	HIS	Class II	1995-09-22
K943064	Kimono (Condoms)	Mayer Laboratories	HIS	Class II	1995-09-22
K954061	Poly-Lite Model 1000	Pro-Den Systems, Inc.	EBZ	Class II	1995-09-21