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 1923 of 3531

510(k) clearances, page 1923 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K970187	Runyon Large Volume Paracentesis Kit	Gi Supply	LRO	Class II	1997-02-14
K970186	Gi Supply Paracentesis Pump	Gi Supply	BTA	Class II	1997-02-14
K970085	Sealite Sciences Aqualite Fsh	Sealite Sciences, Inc.	CGJ	Class I	1997-02-14
K965248	Bemis Two Gallon Sharps Container	Bemis Mfg. Co.	FMI	Class II	1997-02-14
K965201	O.r. Scrub Prep Tray, Sterile, Disposable	Trinity Laboratories, Inc.	LRO	Class II	1997-02-14
K965138	Dentinsense B/c	Centrix, Inc.	KLE	Class II	1997-02-14
K965086	Cygnus Electrosurgical Tip Cleaner	Madison Polymeric Engineering	GEI	Class II	1997-02-14
K964955	Flexfinder Guidewire (Regular Shaft/stiff Shaft) Marked Ink Bands Encap+/guidewire(regular Shaft/stiff Shaft) No Marking	Flexmedics	OCY	Class II	1997-02-14
K964827	Prod. No. 01-132 - Suture Removal Kit	Continental Medical Laboratories, Inc.	MCZ	Class I	1997-02-14
K964800	Jiawang Pre-Powdered Vinyl Examination Gloves	Shanghai Jiawang Industrial Co., Ltd.	LYZ	Class I	1997-02-14
K964765	Chiron Diagnostics Acs: 180 Carbamazepine Assay	Chiron Diagnostics Corp.	KLT	Class II	1997-02-14
K964684	Softouch	Sahar Technologies, Inc.	GEX	Class II	1997-02-14
K964658	Oasis	Sonotech, Inc.	ITX	Class II	1997-02-14
K964653	Oasis Humidifier	Respironics, Inc.	BTT	Class II	1997-02-14
K964599	Trustex Chocolate Flavored Condom in Black Color	Line One Laboratories	HIS	Class II	1997-02-14
K964598	Trustex Cola Flavord Condom	Line One Laboratories	HIS	Class II	1997-02-14
K964543	Infrasonics Adult Ventilator Trending Option	Medtronic, Inc.	CBK	Class II	1997-02-14
K964358	Amseal Surgical Face Mask	American Seal Co.	FXX	Class II	1997-02-14
K964171	Vasoview Balloon Dissection System	Origin Medsystems, Inc.	GCJ	Class II	1997-02-14
K963981	Vygon Bionector with Extension Set	Vygon Corp.	FPA	Class II	1997-02-14
K963505	Tenet Mlti-Positioning Surgical Stirrup System	Tenet Medical Engineering	HHP	Class II	1997-02-14
K963441	Baldur Vinyl Powdered Gloves	Hti Trading Group	LYZ	Class I	1997-02-14
K963131	Graseby Andersen's, Integrity S700	Graseby Andersen	BZG	Class II	1997-02-14
K961252	Dsxl Diffusion Spirometer	Inair, Ltd.	BTY	Class II	1997-02-14
K961246	Sjm Seguin Annuloplasty Ring Model Sar-M	Abbott Medical	KRH	Class II	1997-02-14
K960727	Evenflo Natural Mother Electric Breast Pump Kit	Evenflo Company, Inc.	HGX	Class II	1997-02-14
K960640	Semm Set for Moto Drive Wisap #7689 Ssm (Modification)	Wisap Gesellschaft Fur Wissenschaftl. App. Bau mbH	HET	Class II	1997-02-14
K941784	Ventana Anti-Cd8 Primary Antibody	Ventana Medical Systems Inc	DEH	Class II	1997-02-14
K941604	Ventana Anti-Cd4 Primary Antibody	Ventana Medical Systems Inc	DEH	Class II	1997-02-14
K964953	In-Tac Bone Anchor System	Influence, Inc.	HXJ	Class I	1997-02-13
K964769	Versys Hip System--Fiber Metal Taper Hip Prosthesis	Zimmer GmbH	LPH	Class II	1997-02-13
K964591	Trustex Grape Flavored Condom in Purple Color	Line One Laboratories	HIS	Class II	1997-02-13
K964079	Speedband Multiple Band Ligator	Boston Scientific Corporation	FHN	Class II	1997-02-13
K963940	Exeter Mesh	Howmedica Corp.	JDJ	Class II	1997-02-13
K963729	Sd-610M(also Known as Standard TENS, Sd-609M,sd-611M, Glc-I Standard)	Skylark Device Co., Ltd.	GZJ	Class II	1997-02-13
K963466	Pediatric Limb Holder	DeRoyal Industries, Inc.	FMQ	Class I	1997-02-13
K963285	Ems Swiss Lithoclast Lithotripter	E.M.S. - Electro Medical Systems SA	FFK	Class II	1997-02-13
K963148	Nexgen Complete Knee Solution	Zimmer GmbH	JWH	Class II	1997-02-13
K963045	Synthes (u.s.a.) Universal Sacral System	Synthes (USA) Products LLC	MNH	Class II	1997-02-13
K970365	Passy-Muir O2 Adapter; Pma2000	Passy-Muir, Inc.	JOH	Class II	1997-02-12
K965162	Lukens Pga, (Polyglycolic Acid) Synthetic Absorbable Surgical Suture,coated, Braided-U.s.p.	Lukens Medical Corp.	GAM	Class II	1997-02-12
K965069	Anspach Suture Anchor	The Anspach Effort, Inc.	MBI	Class II	1997-02-12
K964846	Implatech Rp Medical Grade Silicone Gel Sheeting	Implantech Associates Inc	MDA	Class I	1997-02-12
K964783	Epidural Mini Kit, Eldor Combined Spinal/epidural Kit	Alexander Medical, Inc.	CAZ	Class II	1997-02-12
K963808	Choice Powered Wheelchair	American Medical Technology, Inc.	ITI	Class II	1997-02-12
K963700	Metagen High Tibial Osteotomy System	Metagen, LLC	HRS	Class II	1997-02-12
K963683	Tru-Pulse Laser (Modified)	Tissue Technologies, Inc.	GEX	Class II	1997-02-12
K963326	Breathe Fit	Cambridge Assoc.	LWF	Class I	1997-02-12
K963115	Trocar Cannula	United States Surgical, A Division of Tyco Healthc	GCJ	Class II	1997-02-12
K963101	B-P Hemispherical Acetabular Component	Endotec, Inc.	LPH	Class II	1997-02-12