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 1744 of 3531

510(k) clearances, page 1744 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K990668	Powder Free Blue Nitrile Glove	TG Medical Sdn Bhd	LZA	Class I	1999-06-03
K990483	Retrox Rx 45-Jbp 124774, 53-Jbp 124775, 53-Bp 124776, 60-124777	BIOTRONIK AG	DTB	Class III	1999-06-03
K990469	Lamitrode Leads	Abbott Medical	GZB	Class II	1999-06-03
K990431	Aia-Pack Ca 125	Tosoh Medics, Inc.	LTK	Class II	1999-06-03
K984600	Metra Ps Procedure Kit	Inlet Medical, Inc.	GCJ	Class II	1999-06-03
K984035	Xk-95 High Speed Motor Drill System	Komet Medical	HBE	Class II	1999-06-03
K983996	Spacelabs Medical Ultraview Digital Telemtry System	GE Healthcare	MHX	Class II	1999-06-03
K981860	A P Harness	Paraworks Enterprise, Ltd.	KMK	Class I	1999-06-03
K991552	Synthes Pediatric Rod System	Synthes (USA) Products LLC	MNH	Class II	1999-06-02
K991432	Biocheck Total T4 Enzyme Immunoassay Test Kit, Model Bc-1007	BioCheck Inc	KLI	Class II	1999-06-02
K991311	Total T3 Enzyme Immunoassay Test Kit, Model Bc-1005	BioCheck Inc	CDP	Class II	1999-06-02
K991236	General Purpose Neoflex Transducer Cover, Edocavity Neoflex Transducer Cover, Surgi-Tip Intraoperative Transducer Cover,	CIVCO Medical Instruments Co., Inc.	ITX	Class II	1999-06-02
K990922	Osteonics Spinal System Versatile Cross Connector	Howmedica Osteonics Corp	KWP	Class II	1999-06-02
K990717	Fixion Intramedullary Nailing System	Disco-O-Tech Medical Technologies, Ltd.	HSB	Class II	1999-06-02
K990658	Thyrochek One-Step Whole Blood Rapid Tsh Assay	Little Nell Labs, Inc.	JLW	Class II	1999-06-02
K990221	Intracoil Peripheral Stent	Intratherapeutics, Inc.	JCT	Class II	1999-06-02
K982646	Ailee Sutures and Ailee Needles	Myco Medical Supplies Inc	GAL	Class II	1999-06-02
K991813	Uni-Graft K Dv Vascular Graft	Atrium Medical Corporation	DSY	Class II	1999-06-01
K991707	Modification to Access Cea Reagents for Use on the Access Immunoassay Analyzer, Models 33200, 33205, 33209, 33206	Beckman	DHX	Class II	1999-06-01
K991688	Wrist Type Digital Blood Pressure Monitor, Model Hd-303S	Jawon Medical Co., Ltd.	DXN	Class II	1999-06-01
K991641	At Home Cocaine & Thc Screening Test, Model 9170	Phamatech Inc.	MVO	Unclassified	1999-06-01
K991372	Crp	Abbott Medical	DCN	Class II	1999-06-01
K991302	Smartlight Digital Film Viewer, Models Sl 4000Plus, Sl 2000Plus	Smartlight, Inc.	IXC	Class I	1999-06-01
K991227	8Mm Forged Cemented Stem	Encore Orthopedics, Inc.	JDI	Class II	1999-06-01
K991226	Foundation Porous Hip Stem	Encore Orthopedics, Inc.	LZO	Class II	1999-06-01
K991181	Modification of N Protein Standard Sl	Siemens Healthcare Diagnostics Inc.	JIX	Class II	1999-06-01
K991123	Perfecta Rs Lateralized Hip Stem, Bridge Hip System	Wrightmedicaltechnologyinc	LPH	Class II	1999-06-01
K991101	Coag-a-Mate Max	bioMerieux, Inc.	GKP	Class II	1999-06-01
K991051	Ksea Epiduroscope	Karl Storz Endoscopy-America, Inc.	HRX	Class II	1999-06-01
K990943	Vitros Immunodiagnostic Products Cea Calibrators, Vitros Immunodiagnostic Products Cea Reagent Pack	Ortho-Clinical Diagnostics, Inc.	DHX	Class II	1999-06-01
K990850	Coopersurgical Coagulator for Tattoo Removal	CooperSurgical, Inc.	KNS	Class II	1999-06-01
K990353	Stainless Steel Fixation Pins	Bregma International Trading Company, Ltd.	JDW	Class II	1999-06-01
K990351	Bone Screws	Bregma International Trading Company, Ltd.	HWC	Class II	1999-06-01
K990321	Alphamed Gemini Sensor, Snoring Sensor	Alphamed, Inc.	MNR	Class II	1999-06-01
K990154	Karl Storz Direct Coupled Interface (Dci 5) Camera System	Karl Storz Imaging, Inc.	FWF	Class I	1999-06-01
K984468	Vital Pep	Vital Signs, Inc.	BWF	Class II	1999-06-01
K984290	Implex Radial Head Replacement System	Implex Corp.	KWI	Class II	1999-06-01
K982889	Medpulse Respiratory Vest System, Model 1000	Electromed, Inc.	BYI	Class II	1999-06-01
K981353	Avogel	Avocet Polymer Technologies, Inc.	MDA	Class I	1999-06-01
K991661	Siemens Medical Information Bus (Mib) Protocol Converter	Siemens Medical Solutions USA, Inc.	DQA	Class II	1999-05-28
K991648	Reusable Contour II Nasal Mask	Respironics, Inc.	BZD	Class II	1999-05-28
K991640	Health Aid Premium Pre-Powdered Nitrile Examination Gloves	M.R.G. Industries Berhad	LZA	Class I	1999-05-28
K991612	Sterisharp 2.5-Gallon Rsdc, Model #Rsdc2.5g	Sterilogic Waste Systems, Inc.	MMK	Class II	1999-05-28
K991528	Modification to Tenor Spinal System-Rod/bolt Connector	Danek Medical, Inc.	MNH	Class II	1999-05-28
K991515	Insure Pregnancy Test	Inbios Intl., Inc.	DHA	Class II	1999-05-28
K991462	Qtexx Powder Free Latex Examination Gloves, Polymer Coated	Latexx Partners Bhd.	LYY	Class I	1999-05-28
K991430	Smartprep Centrifuge System	Terumo BCT, Ltd	JQC	Class I	1999-05-28
K991299	Modification to Cardiac Status Ck-Mb/myoglobin Rapid One-Step Test, Lifesign Mi Ck-Mb/myoglobin, Lifesign Ck-Mb/myoglobi	Princeton BioMeditech Corp.	JHT	Class II	1999-05-28
K991175	Modification to Alcyon Direct Bilirubin	Abbott Medical	CIG	Class II	1999-05-28
K991158	Latex Examination Gloves- Powder Free, Sizes Extra Small, Small,medium,large,extra Large	P. T. Tata Rubberindo Industries	LYY	Class I	1999-05-28