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 2026-11-02, 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 1030 of 3531

510(k) clearances, page 1030 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K093976	Raisin Personal Monitor	Proteus Biomedical, Inc.	DXH	Class II	2010-03-25
K093896	Ethicon Endo Surgery Slotted Anoscope	Ethicon Endo-Surgery Inc	FER	Class II	2010-03-25
K093831	Fully Automatic (Nibp) Blood Pressure Monitor, Model Hl868rt	Health & Life Corporation	DXN	Class II	2010-03-25
K093406	Morpheus Smart Picc CT and Procedure Kit Model 12105509, 12105519	Boston Scientific Corporation	LJS	Class II	2010-03-25
K092437	Codman Sterilization Containers	Cerenovus, Inc.	KCT	Class II	2010-03-25
K091978	Dbb-06 Hemodialysis Delivery System	Nikkiso Co., Ltd.	KDI	Class II	2010-03-25
K091538	Pressure Release Valve W/audible, Model Prv 20/40/60; with T6 Adapter, Model Prv 120/140/160; T6 Adapter, Model T6-100	Wet Nose Technologies, LLC	CBP	Class II	2010-03-25
K100507	Xres Blood Collection Reservoir	Corcym Inc.	DTN	Class II	2010-03-24
K100385	Nuby Natural Touch Rhythm Dual Action Electric Breast Pump	Luv N' Care Ltd	HGX	Class II	2010-03-24
K100326	Powder-Free Vinyl Patient Examination Gloves	Tangshan Hongda Plastci Products Co, Ltd.	LYZ	Class I	2010-03-24
K100317	Digital X-Ray Imaging System (Pax-Primo) Model Pax-Primo	Vatech Co., Ltd.	MUH	Class II	2010-03-24
K100280	Gyncare Morcellex Tissue Morcellator	Ethicon, Inc	HET	Class II	2010-03-24
K100186	Mysono U5 Diagnostic Ultrasound System	Medison Co., Ltd.	IYN	Class II	2010-03-24
K100162	Multiple Private Label	Biogreen Yields Sdn.Bhd	LZA	Class I	2010-03-24
K093984	Pica Whole Body MRI System Model Tms-MRI-3500Wb-01	Time Medical Limited	LNH	Class II	2010-03-24
K093808	Incite Innovation Stand Alone Interbody Fusion Device	Incite Innovation, LLC	OVD	Class II	2010-03-24
K093003	Bonastent Biliary	Boston Scientific Corporation	FGE	Class II	2010-03-24
K092046	Bi-Ostetic Foam and Putty, Generos Foam and Putty	Berkeley Advanced Biomaterials	MQV	Class II	2010-03-24
K091890	Extended Use Aldahol High Level Disinfectant	Healthpoint, Ltd.	MED	Class II	2010-03-24
K094044	Spiral Laminar Flow Vascular Arteriovenous Graft	Tayside Flow Technologies Limited	DSY	Class II	2010-03-23
K094006	Opal Bond Mv	Ultradent Products Inc.	DYH	Class II	2010-03-23
K093048	D-Storm 810Nm, D-Storm 980Nm	LIGHT INSTRUMENTS Ltd.	GEX	Class II	2010-03-23
K090364	Extra Pta Balloon Catheter with Embolic Protection Feature	Angioslide, Ltd.	LIT	Class II	2010-03-23
K083842	Rotem Delta Thromboelastometry System	Pentapharm AG	JPA	Class II	2010-03-23
K100350	Hoveround Teknique Gt Power Wheelchair, Model# Teknique Gt	Hoveround Corp.	ITI	Class II	2010-03-22
K100345	Systems Integration Model: Endoalpha	Olympus Medical Systems Corp.	ODA	Class II	2010-03-22
K100339	Powder-Free Vinyl Patient Examination Gloves	Tangshan Changrong Glove Co., Ltd.	LYZ	Class I	2010-03-22
K100327	Heartway Power Chair, P23	Heartway Medical Products Co., Ltd.	ITI	Class II	2010-03-22
K100303	Angiosculpt Pta Scoring Balloon Catheter Model 2039-Xxyy, 2076-Xxyy, 2092-Xxyy, 2105-Xxyy	Spectranetics Corp.	PNO	Class II	2010-03-22
K094047	18 Standard Wheelchair, Model Ms005-4, 18 Reclining Wheelchair , Model Ms008-1, 14 Pediatric Wheelchair	Modern Rehabilitation Solutions Co., Ltd.	IOR	Class I	2010-03-22
K093998	Kneealign System with Reference Sensor	OrthAlign, Inc.	OLO	Class II	2010-03-22
K093946	Hoveround Hoverglide Model Hoverglide Mk-2	Hoveround Corp.	ILK	Class II	2010-03-22
K093791	Gore Dryseal Sheath	W. L. Gore & Associates, Inc.	DYB	Class II	2010-03-22
K093732	Advia Chemistry Drug Calibrator I Model 10376770	Siemens Healthcare Diagnostics Inc.	JIX	Class II	2010-03-22
K093731	Vpap III St-a	ResMed Corp	MNS	Class II	2010-03-22
K093535	Autolog Autotransfusion System	Medtronic, Inc.	CAC	Class II	2010-03-22
K093240	Belray II	Takara Belmont Corporation	EHD	Class II	2010-03-22
K092584	Laport	Mgb Endoskopische Gerate GmbH (Berlin)	GCJ	Class II	2010-03-22
K100457	Opus Speedscrew System	ArthroCare Corporation	HWC	Class II	2010-03-19
K100293	Advia Centaur Calibrator 30, Models 10379811/10379810	Siemens Heatlhcare Diagnostics, Inc.	JIT	Class II	2010-03-19
K100202	Slit Lamp Bo 900, Bq 900, Bp900	Haag-Streit AG	HJO	Class II	2010-03-19
K100083	Esthetica	Sybron Dental Specialties, Inc.	EBF	Class II	2010-03-19
K100080	Reprocessed Trocars, Model B5lt and Cb5lt	Stryker Sustainability Solutions	NLM	Class II	2010-03-19
K093983	Smple Plate and Screws	Biomet Trauma (Aka Ebi, LP)	HRS	Class II	2010-03-19
K093492	Mission Clinicheck Assayed Chemistry Control, Level 1&2, Mission Clinical Calibrator	DIAMOND DIAGNOSTICS Inc	JJY	Class I	2010-03-19
K093115	Kimberly-Clark Kc100 Surgical Gown, Model Kc100	Kimberly-Clark Corporation	FYA	Class II	2010-03-19
K092848	Elecsys Troponin T Calcheck 5	Roche Diagnostics GmbH	JJX	Class I	2010-03-19
K091564	Nbm-200Mp Pulse Oximetry Device	Orsense Ltd	DQA	Class II	2010-03-19
K091120	Medpor Contain Implant	Porex Surgical, Inc.	NPK	Class II	2010-03-19
K100226	Wireless Body Temperature Monitor Model Btm-Dix Series (Btm-Dic,d,e,f,g & H)	Rio Flexon Technology Co., Ltd.	FLL	Class II	2010-03-18