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 2026-11-02, 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 959 of 3531

510(k) clearances, page 959 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K102496	Powerheart AED G3 Semi-Automatic, Powerheart AED G3 Automatic, Powerheart AED G3 Pro, Powerheart AED G3 Plus	ZOLL Medical Corporation	MKJ	Class III	2011-06-09
K111379	Equinoxe Uhmwpe 12* Posterior Augment Pegged Glenoid, Small / Medium / Large / Extra-Large, Left / Right	Exactech, Inc.	KWS	Class II	2011-06-08
K111339	Hemostasis Managment System Plus (Hms-Plus)	Medtronic, Inc.	JOX	Class II	2011-06-08
K111315	Multipurpose Drainage Catheter	Boston Scientific Corporation	FGE	Class II	2011-06-08
K111111	Endopath Ets 35Mm Endoscopic Linear Cutter and Reloads, and Ets-Flex 35Mm Endoscopic Articulating Linear Cutter and Relo	Ethicon Endo-Surgery Inc	GDW	Class II	2011-06-08
K111007	Midwest Reprocessing Center Reprocessed Lncs Sessors; Midwest Reprocessing Center Reprocessed Oximax Sensors; Midwest Re	Midwest Reprocessing Center, LLC	NMD	Class II	2011-06-08
K110883	J-Style Bone Marrow Biopsy / Aspiration Needle with Snare-It Marrow Acquisition Cannula	Busse Hospital Disposables	KNW	Class II	2011-06-08
K110728	Imesh Tacker	Easylap, Ltd.	GDW	Class II	2011-06-08
K110693	Paceart Optima System Software	Medtronic, Inc.	KRE	Class II	2011-06-08
K110284	Novel III Spinal Fixation and Adjustable Bridge System	Medyssey Co., Ltd.	MNI	Class II	2011-06-08
K110272	Sterile Polyisoprene Powder-Free Surgical Gloves Tested for Use with Chemotherapy Drug	Medtronic, Inc.	KGO	Class I	2011-06-08
K110070	Tsrh Spinal System	Medtronic Sofamor Danck USA, Inc.	NKB	Class II	2011-06-08
K103724	10 Mp Grayscale Flat Panel Display (Gx 1030)	Eizo GmbH	LLZ	Class II	2011-06-08
K103637	Erka. Perfect-Aneroid	Erka Kallmeyer Medizintechnik GmbH	DXQ	Class II	2011-06-08
K103429	Biograph Mmr	Siemens Medical Solutions USA, Inc.	OUO	Class II	2011-06-08
K110158	Illuminating Sinus Seeker	Entellus Medical, Inc.	LRC	Class I	2011-06-07
K103086	Dynarex Intermittent Catheters, Male, Female, Pediatric	Dynarex Corp.	EZD	Class II	2011-06-07
K111041	Mini Variable System	TORNIER Inc.	HRS	Class II	2011-06-06
K111017	Cleartemp	Ultradent Products Inc.	EMA	Class II	2011-06-06
K110972	Powder Free Vinyl Patient Examination Gloves, Light Yellow Color	Ppp Medical and Safety Products Company Limited	LYZ	Class I	2011-06-06
K110753	Midwest Rdh Freedom Cordless Prophy System	Dentsply International, Inc.	EKX	Class I	2011-06-06
K110527	K-Pack Surshield Needle, Hypodermic Needle for Single Use	Terumo Europe N.V.	FMI	Class II	2011-06-06
K110405	Trublue Nasal Mask	Respironics, Inc.	BZD	Class II	2011-06-06
K103839	Behind Ear Gentle Touch Thermometer	Kaz, Inc.	FLL	Class II	2011-06-06
K103210	Tyvek Self-Seal Pouches with Sterrad, Tyvek Rolls with Sterrad, Tyvek Heat-Seal with Sterrad Chemical Indicators	Advanced Sterilization Products	FRG	Class II	2011-06-06
K102623	Blue Powderfree Nitrile Examination Glove	PT. Medisafe Technologies	LZA	Class I	2011-06-06
K101733	Reusable, Disposable Laparoscopic Instrument and Surgical Device and Accessories	Sac, LLC dba Pinnacle Medical Surgical	GCJ	Class II	2011-06-06
K111445	Discovery Nm 630	GE Healthcare	KPS	Class II	2011-06-03
K111442	V-Loc 180 Absorbable Reload, V-Loc Pbt Non-Absorbable Reload, Endo Stitch (Tm) Endoscopic Suturing Device, Sils (Tm)...	Covidien, Formerly US Surgical A Divison of Tyco H	GAM	Class II	2011-06-03
K111292	Luminos Agile	Siemens Medical Solutions USA, Inc.	JAA	Class II	2011-06-03
K111093	Billy Boy Male Latex Condom	Mapa GmbH	HIS	Class II	2011-06-03
K110829	Ace Stapler and Cartridge	Barosense, Inc.	OCW	Class II	2011-06-03
K110769	Amsco Warming Cabinet	STERIS Corporation	LGZ	Class II	2011-06-03
K110732	Emulsion Sb	Prugen IP Holdings, Inc.	FRO	Unclassified	2011-06-03
K110645	Bio Z Cardio Profile Hemodynamic Monitor	FUJIFILM SonoSite,Inc.	DSB	Class II	2011-06-03
K110508	Suglue-10	3M Espe AG	EMA	Class II	2011-06-03
K110275	Ortho Easy Pin	Forestadent Bernhard Forster GmbH	OAT	Class II	2011-06-03
K103266	Istand	Optovue Inc.	HLI	Class II	2011-06-03
K102767	Cardio Xp	Bionet Co., Ltd.	DPS	Class II	2011-06-03
K102614	Avivafix Conductive Garment-Knee/shoulder/upper Back, Type 40	Bio-Medical Research, Ltd.	GXY	Class II	2011-06-03
K102566	Owl Cannulae	Diros Technology, Inc.	GXI	Class II	2011-06-03
K101627	Iplan	Brainlab, Inc.	HAW	Class II	2011-06-03
K111252	Acuity (Tm) Cut-Away (Tm) Guide Catheters 6F and 8F	Boston Scientific Corporation	DQY	Class II	2011-06-02
K110773	Tornier Insite Ft Suture Anchor	TORNIER Inc.	MBI	Class II	2011-06-02
K110688	Mylabgold	Esaote S.p.A.	IYO	Class II	2011-06-02
K110669	Tampax C Plastic Tampons, Unscented	Procter & Gamble Co.	HEB	Class II	2011-06-02
K110658	Aptus Cannulated Compression Screws	Medartis AG	HWC	Class II	2011-06-02
K110617	Mini Trek Rx 1.20 Mm Coronary Dilatation Catheter, Mini Trek Otw 1.20 Mm Coronary Dilatation Catheter	Abbott Vascular	LOX	Class II	2011-06-02
K110143	Het Bipolar Electrocautery Forceps	Het Systems, LLC	GEI	Class II	2011-06-02
K103737	Omni II Patient Monitor	Infinium Medical, Inc	MWI	Class II	2011-06-02