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 2322 of 3531

510(k) clearances, page 2322 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K923805	Power Pillow	Nova Teknic, Inc.	BXB	Class I	1993-02-12
K923804	Portable Lift Seat	Frank H. Speckhart, P.E.	INO	Class II	1993-02-12
K923789	Mayfield Adult Disposable Skull Pin	Ohio Medical Instrument Co., Inc.	HBL	Class II	1993-02-12
K923640	Gk Dental Amalgam Alloy	The Patron Trading Corp.	EJJ	Class II	1993-02-12
K923637	Arjo-Century Arm and Leg Tank System	Arjo-Century, Inc.	ILJ	Class II	1993-02-12
K923579	Minividas Instrument	Biomerieux Vitek, Inc.	JJE	Class I	1993-02-12
K923554	Kodak Ektascan	Eastman Kodak Company	IXW	Class II	1993-02-12
K923366	Tilt Seating System	Labac Systems, Inc.	KNN	Class I	1993-02-12
K923245	Triguide-Plus Guiding Catheter	Scimed Life Systems, Inc.	DQY	Class II	1993-02-12
K923085	Quicklamp System	Disco, Inc.	DXC	Class II	1993-02-12
K922871	Unifit Femoral Stem	Osteo Technology, Inc.	JDI	Class II	1993-02-12
K922868	Thompson Type Hip Prothesis	Osteo Technology, Inc.	KWA	Class III	1993-02-12
K922866	Oti Bone Plug	Osteo Technology, Inc.	JDI	Class II	1993-02-12
K922864	Mueller Type Femoral Stem	Osteo Technology, Inc.	JDI	Class II	1993-02-12
K922863	Eurostem Hip Prothesis System	Osteo Technology, Inc.	JDI	Class II	1993-02-12
K922862	Charnley Type Hip Prothesis	Osteo Technology, Inc.	JDI	Class II	1993-02-12
K922860	Austin-Moore Type Hip Prosthesis	Osteo Technology, Inc.	JDI	Class II	1993-02-12
K922356	Flow Control Valve, Cat. No. Acv-38	American Omni Medical, Inc.	MJJ	Class II	1993-02-12
K922101	Angiographic Catheter -- Modification	Interventional Therapeutics Corp.	DQO	Class II	1993-02-12
K921923	Titanium Ventilation Tubes	Exmoor Plastics Limited	ETD	Class II	1993-02-12
K920767	Nycoplastin	Nycomed Pharma AS	GJS	Class II	1993-02-12
K920661	Vidas Cmv Igg Assay	Vitek Systems, Inc.	LFZ	Class II	1993-02-12
K920351	Pcx 650Hf Radiographic X-Ray	Control-X, Inc.	IZO	Class I	1993-02-12
K920349	Pcx 1050Hf Radiographic X-Ray Generator	Control-X, Inc.	IZO	Class I	1993-02-12
K915876	Hotpad	Ten Comfort Corp.	IME	Class I	1993-02-12
K915584	Crk Condylar Resurfacing Total Knee	Implantology Corp.	JWH	Class II	1993-02-12
K914994	Hpd Heater Bases	Hpd Medical, Inc.	BZE	Class II	1993-02-12
K914816	American Artificial Larynx	Ultravoice, LLC.	ESE	Class I	1993-02-12
K926004	Endoscope and Accossories	Endomedix	FGB	Class II	1993-02-10
K925706	Reusable Finger Clip Recording Electrode	Chalgren Enterprises, Inc.	GXY	Class II	1993-02-10
K925267	Grasping Forceps or Retrieval Forceps	Annex Medical, Inc.	GCJ	Class II	1993-02-10
K924807	Reusable Incontient Underpad	Perfect Fit Industries, Inc.	FMW	Class I	1993-02-10
K924419	Cir Latex Gloves	Crocker Industrial Resources Sdn. Bhd.	LYY	Class I	1993-02-10
K924284	Microsurge Director Articulating Instruments	Micromec Surgical, Inc.	GCJ	Class II	1993-02-10
K924266	Doctor's Choice Powder Free Latex Exam Gloves	Chesire Laboratories	LYY	Class I	1993-02-10
K924128	Cholangiography Catheter	Applied Medical Resources Corp	GBZ	Class I	1993-02-10
K923929	Perry Powder-Free Gloves, Style 45G	Smith & Nephew Perry	KGO	Class I	1993-02-10
K923916	Voyagr Series Diagnostic Ep Catheters	Cardiorhythm	DRF	Class II	1993-02-10
K923915	Torqr Series Diagnostic Ep Catheters	Cardiorhythm	DRF	Class II	1993-02-10
K923862	Latex Patient Examination Glove (Powder Free)	Siam Sempermed Corp., Ltd.	LYY	Class I	1993-02-10
K923547	Minivasive Laparoscopy Instruments	Minvasive Devices, Inc.	GCJ	Class II	1993-02-10
K923343	Hewlett-Packard Model M1020a Pulse Oximeter	Hewlett-Packard Co.	DQA	Class II	1993-02-10
K922288	Holder, Pediatric Position	Yamashita and Hemsley Business Trust	BWN	Class I	1993-02-10
K921638	System 90 Intra-Aortic Balloon Pump Console	Datascope Corp.	DSP	Class II	1993-02-10
K921338	Anspach Mini-Plating System	The Anspach Effort, Inc.	HRS	Class II	1993-02-10
K930252	Babyset and Pac (Pulmonary Assist Circuit)	Bird Life Design	CAI	Class I	1993-02-09
K925895	Etex Hip Replacement System	Etex Corp.	JDI	Class II	1993-02-09
K923525	Nucleotome 3.5 Mm Automated Percutaneous Lumbar	Surgical Dynamics Ltd	HRX	Class II	1993-02-09
K923277	Foundation Knee System	Encore Orthopedics, Inc.	JWH	Class II	1993-02-09
K923142	Arthrex Plus	Arthrex GmbH	HRX	Class II	1993-02-09