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 1809 of 3531

510(k) clearances, page 1809 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K980822	Titanium Peg System	Fci Ophthalmics, Inc.	MQU	Class II	1998-07-09
K980538	Laser Lancet Lb100	Transmedica Intl., Inc.	GEX	Class II	1998-07-09
K980212	Mityvac	Prism Technologies, Inc.	HDB	Class II	1998-07-09
K974801	Single Channel Balloon Cannula	Conkin Surgical Instruments Ltd.	HDP	Class II	1998-07-09
K974655	Preptech(tm) 200 Cavity Preparation System	Prep Technology Corp.	KOJ	Class II	1998-07-09
K972750	Taka Aneurysm Clip	V. Mueller Neuro/Spine	HCH	Class II	1998-07-09
K981615	Ksea Uropump	Karl Storz Endoscopy-America, Inc.	LJH	Class II	1998-07-08
K981612	All Silicone Foley Catheter, Two-Way Foley Catheter, Three-Way Foley Catheter, Two-Way Radiopaque Foley Catheter	Rochester Medical Corp.	EZL	Class II	1998-07-08
K981483	Ebi Dfs Joint Fixator, Model 02800	Electro-Biology, Inc.	KTT	Class II	1998-07-08
K981301	Speed-Cut Automatic Biopsy System	Gallini U.S., LLC	KNW	Class II	1998-07-08
K981294	Odyssey Instrumentation System	Automata Instrumentation, Inc.	FIZ	Class II	1998-07-08
K980501	Skintoner System	Fuller Research Corp.	GEX	Class II	1998-07-08
K974698	Siemens Sc9000/sc9015 Enhanced with 12-Lead St Segment Analysis	Siemens Medical Solutions USA, Inc.	DSI	Class II	1998-07-08
K981930	Unicap Thyroid Peroxidase Igg	Pharmacia & Upjohn Company LLC	JZO	Class II	1998-07-07
K981883	Roche Diagnostics, Boehringer Mannheim Corporation Liquid Direct Bilirubin Reagent, Catalog Number 1877844	Boehringer Mannheim Corp.	CIG	Class II	1998-07-07
K981828	Galileo Disposable Hysteroscopes	Netoptix Corp.	HIH	Class II	1998-07-07
K981592	Acs:centaur Afp	Chiron Diagnostics Corp.	LOQ	Class II	1998-07-07
K981559	Unicap Thyroglobulin Igg Assay, Unicap Thyroid Peroxidase Igg Assay	Pharmacia & Upjohn Company LLC	JZO	Class II	1998-07-07
K981488	Glove, Oaktex Examination, Glove, Patient Examination	Oak Carolina, Inc.	LYZ	Class I	1998-07-07
K981479	Il Test Pt-Fibrinogen Recombinant	Instrumentation Laboratory Co.	GJS	Class II	1998-07-07
K981428	Anu Ice	Cryoptherapy Pain Relief Products, Inc.	LKX	Unclassified	1998-07-07
K981322	Cutalon Nylon Polyamide Surgical Suture	Genzyme Surgical Product (Genzyme Biosurgery)	GAR	Class II	1998-07-07
K981321	Bipolar Forceps Set (Modular)	Richard Wolf Medical Instruments Corp.	GEI	Class II	1998-07-07
K980487	Carpenter-Edwards Classic Ring with Duraflo Treatment Models 4425 (Mitral) and 4525 (Tricuspid), Carpenter-Edwards Physm	Baxter Edwards	KRH	Class II	1998-07-07
K980177	Sugitron Model: Iec	Ellman Intl., Inc.	GEI	Class II	1998-07-07
K974799	Hemochron Jr Generation II, Hemochron Jr Signature	Accriva Diagnostics, Inc.	JPA	Class II	1998-07-07
K972899	Cypress Medical Products Aneroid Sphygmomanometer	Cypress Medical Products LLC	DXQ	Class II	1998-07-07
K972328	Percutaneous Breast Biopsy (Pbb)	Urothealth System, Inc.	KNW	Class II	1998-07-07
K972255	Pulse Biomedical Inc, Qrs Card S-T Segment Analysis Monitoring System	Pulse Biomedical, Inc.	LOS		1998-07-07
K982022	Vigil Hemoglobin (Hbalc) Controls	Siemens Healthcare Diagnostics Inc.	JJX	Class I	1998-07-06
K981882	Cardiac Status Ck-Mb/myoglobin/troponin I Rapid Test	Princeton BioMeditech Corp.	MMI	Class II	1998-07-06
K981800	Sentinel Cholinesterase Liquid Model Number 17.019A & 17.606	Equal Diagnostics, Inc.	HIH	Class II	1998-07-06
K981773	Drager-Vapor 19.3	Draeger, Inc.	CAD	Class II	1998-07-06
K981574	Opti-Free Express Multi-Purpose Solution	Alcon, Inc.	LPN	Class II	1998-07-06
K981308	International Respiratory Systems, Inc.'s Manual Pulmonary Resuscitator with Rubber Compression Bag	International Respiratory Systems, Inc.	BTM	Class II	1998-07-06
K981307	International Respiratory Systems, Inc.'s Manual Resusciator	International Respiratory Systems, Inc.	BTM	Class II	1998-07-06
K981262	Cusa Excel Ultrasonic Surgical Aspirator System	Medtronic, Inc.	LFL	Unclassified	1998-07-06
K980877	Etest Cefdinir	Ab Biodisk	JWY	Class II	1998-07-06
K980775	Complete Brand Multi-Purpose Solution	Allergan	LPN	Class II	1998-07-06
K980638	Adi Syphilis Rpr Liquid Controls	Ampcor Diagnostics, Inc.	GMP	Class II	1998-07-06
K974837	Igel(r) 56 (Hefilcon C) Soft (Hydrophlic) Contact Lens	Igel Vision Care Pte, Ltd.	LPL	Class II	1998-07-06
K974715	Advantage 3D Xr	GE Healthcare	JAK	Class II	1998-07-06
K974025	Anspach Shielded Attachment	The Anspach Effort, Inc.	GFF	Class I	1998-07-06
K971252	Sevrain Cranial Clamp	Ikonos Corp.	GXN	Class II	1998-07-06
K982217	Ac/ad Linearity Verifiers	Sc Calibrators & Controls, LLC	DIF	Class I	1998-07-02
K981456	Baby Pacifier Digital Thermometer	K-Jump Health Co., Ltd.	FLL	Class II	1998-07-02
K981374	Porex Nostril Retainers	Porex Surgical, Inc.	LYA	Class I	1998-07-02
K981335	Ariston Phc Liner	Ivoclar North America, Inc.	EMA	Class II	1998-07-02
K981264	Ariston Phc	Ivoclar USA, Inc.	EBF	Class II	1998-07-02
K981251	Kyphon Inflatable Bone Tamp	Medtronic, Inc.	HRX	Class II	1998-07-02