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 2026-10-29, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 824 of 3530

510(k) clearances, page 824 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K123390	Pediguard Nerve Detector System	Spineguard, Inc.	PDQ	Class II	2013-08-08
K121610	Cobas C 501 Tina-Quant Hba1cdx Gen.3 Assay	Roche Diagnostics GmbH	PDJ	Class II	2013-08-08
DEN130005	Quantitation of Organophosphate Metabolites in Urine by Lc/ms/ms	Centers for Disease Control and Prevention	PDY	Class II	2013-08-08
K132259	Bd Veritor System for the Rapid Detection of Flu A+b	Becton Dickinson & Co	PSZ	Class II	2013-08-07
K132256	Bd Veritor System for the Rapid Detection of Flu A+b	Becton Dickinson & Co	PSZ	Class II	2013-08-07
K131722	I.t.s. Extremity Fixation Systems	I.T.S. GmbH	HRS	Class II	2013-08-07
K131642	Rsh Biliary Stone Removal Device	Rsh, LLC	LQR	Class II	2013-08-07
K131512	Katia System	Shanghai Sanyou Medical Co. Ltd	KWQ	Class II	2013-08-07
K131360	Integra Titanium Bone Wedge	Ascension Orthopedic	HRS	Class II	2013-08-07
K131345	Tiarray Dental Implant System	Nasseo, Inc.	DZE	Class II	2013-08-07
K131313	Active Breathing Coordinator	Aktina Medical Corp.	IYE	Class II	2013-08-07
K130932	Firebird Spinal Fixation System	Orthofix SRL	NKB	Class II	2013-08-07
K130608	Quadcut	Medtronic Navigation, Inc	HAW	Class II	2013-08-07
K130148	Foreign Body Hood	United States Endoscopy Group, Inc.	FDS	Class II	2013-08-07
K123904	Prothelial	Mueller Medical International, LLC	FRO	Unclassified	2013-08-07
K132111	Cd Horizon Spinal System	Medtronic Sofamor Danek USA Inc	NKB	Class II	2013-08-06
K131875	Menicon Nect Contact Lens Case	Foresight Regulatory Strategies	LRX	Class II	2013-08-06
K131450	Flash Mini Ostial System - 3.0Mm X 135Cm, Flash Mini Ostial System - 3.5Mm X 8Mm X 135Cm, Flash Mini Ostial System - 4.0	Verge Medical Inc.	LOX	Class II	2013-08-06
K130743	The Kinegraph Vma (Vertebral Motion Analyzer) Software Version 2.0; the Motion Normalizer Patient Handling and Data Coll	Wenzel Spine	LLZ	Class II	2013-08-06
K130126	Signature Personalized Patient Care System - Glenoid Guide System	Zimmer GmbH	MBF	Class II	2013-08-06
K130046	Clearspec Single Use Vaginal Speculum	Clearspec, LLC	HIB	Class II	2013-08-06
K123047	Bracco Diagnostics Inc. CO2 Endoscopic Insufflator in Line Tubing Set	Bracco Diagnostic, Inc.	FCX	Class II	2013-08-06
K122337	Ovusense	Fertility Focus, Ltd.	LHD	Unclassified	2013-08-06
K132190	Expandable Lemaitre Valvulotome, Over-the-Wire Lemaitre Valvulotome	LeMaitre Vascular Inc.	MGZ	Class II	2013-08-05
K131930	Jbaids Anthrax Detection Kit	BioFire Diagnostics, LLC	NHT	Class II	2013-08-05
K131704	Epidose	Sun Nuclear Corporation	IYE	Class II	2013-08-05
K131286	Primatrix Dermal Repair Scaffold	Integra LifeSciences Braintree Inc.	KGN	Unclassified	2013-08-05
K130541	Symmetry Kerrison Disposable Tip Rongeurs	Symmetry Surgical GmbH	HAE	Class II	2013-08-05
K130342	Sauflon Clariti (Somofilcon a) Soft (Hydrophilic) Contact Lens with UV Blocker	Sauflon Pharmaceuticals, Ltd.	LPL	Class II	2013-08-05
K122883	Exp Tibial Inserts and Patellar Components for the Proven Gen-Flex Total Knee System	Globus Medical, Inc.	JWH	Class II	2013-08-05
K122610	Plaxtron CPAP System, Model Ch-Ffm-87Xx/ch-Ffm-88Xx Series	Sen MU Technology Co., Ltd.	BYE	Class II	2013-08-05
K122553	Mission Plus Hb Hemoglobin Testing System	Acon Laboratories, Inc.	GKR	Class II	2013-08-05
K130748	Smith & Nephew Sureshot Distal Targeting System V3.0	Smith & Nephew, Inc.	OLO	Class II	2013-08-04
K132061	Restorelle M, Restorelle Xl	MEDLINE INDUSTRIES, LP - Northfield	OTO	Class II	2013-08-02
K131517	Medrad Twist & Go High Pressure Connector Tubing	Medrad, Inc. / Bayer Medical Care, Inc.	FPK	Class II	2013-08-02
K131493	Sidekick and Usher Support Catheters	C.R. Bard Inc	DQY	Class II	2013-08-02
K131301	Bd Facs Sample Prep Assistant III	Becton Dickinson & Co	PER	Class I	2013-08-02
K131166	Sofia(r) Hcg Fia	Ortho-Clinical Diagnostics, Inc.	JHI	Class II	2013-08-02
K130933	Solutis	Quantel Medical	HQF	Class II	2013-08-02
K123347	Normed Ankle Fix System 4.0 and Normed Ankle Fix Plus System 4.0	Normed Medizin-Technik GmbH	HRS	Class II	2013-08-02
K122063	Intellisave Ax700 Anesthesia System	Philips Anesthesia Care	BSZ	Class II	2013-08-02
K121370	Vectec Disposable Pneumoperitoneum Needle	Vectec	FHO	Class II	2013-08-02
K131305	Chison Diagnostic Ultrasound System, Convex Probe, Lincar Probe, Phased Probe	Chison Medical Imaging Co., Ltd.	IYN	Class II	2013-08-01
K131079	Creganna-Tactx Steerable Sheath Set Symmetric	Creganna Medical Ireland Limited	DYB	Class II	2013-08-01
K130826	Passport Robotic Reducer Cap; Passport Stopcock with Rotating Male Luer	Stryker Corp.	GCJ	Class II	2013-08-01
K130814	Rigidloop Fixation Device (15Mm, 60Mm, Xl, 20Mm, 25Mm, 30Mm, 35Mm, 40Mm, 45Mm, 50Mm, 55Mm	DePuy Mitek, Inc.	MBI	Class II	2013-08-01
K130345	Aqua Lube Natural Lubricant - Regular, Warming	Mayer Laboratories	NUC	Class II	2013-08-01
K130140	Intra-Lock Op Dental Implant	Intra-Lock International	DZE	Class II	2013-08-01
K130109	Endograph Dc	Villa Sistemi Medicali S.p.A.	EHD	Class II	2013-08-01
K130033	Toggleloc Xtender; Toggleloc Xl; Implant Kit Toggleloc; Implant Kit Toggleloc Btb, Extended Toggleloc; Toggleloc; Btb to	Biomet Manufacturing Corp	MBI	Class II	2013-08-01