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 887 of 3530

510(k) clearances, page 887 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K113546	Elecsys Vitamin D Assay Elecsys Vitamin D Calset Elecsys Precicontrol Varia 3 Elecsys Vitamin D Calcheck 5	Roche Diagnostics GmbH	MRG	Class II	2012-07-24
K121907	Dimension Alkaline Phosphatase Flex Reagent Cartridge, Dimension Alkaline Phosphatase Calibrator	Siemens Healthcare Diagnostics Inc.	CJO	Class II	2012-07-23
K121788	Nio 5Mp	Barco N.V.	LLZ	Class II	2012-07-23
K121229	Inspire 8 Dual Hollow Fiber Oxygenator with with Integrated Hardshell Venous/cardiotomy	Corcym Inc.	DTZ	Class II	2012-07-23
K122010	Z6 Diagnostic Ultrasound System	Shenzhen Mindray Bio-Medical Electronics Co.,LTD	IYN	Class II	2012-07-20
K121948	Cr 10-X Digitizer	AGFA Healthcare Corp.	MQB	Class II	2012-07-20
K121835	Domed Tri-Peg Patella, Highly Cross Linked Domed Tri-Peg Patella with Ve	Encore Medical, LP	JWH	Class II	2012-07-20
K121808	Casian, 3.5/4.5 Connectors	K2M, Inc	KWP	Class II	2012-07-20
K121658	Orthofix Acp (Anterior Cervical Plate System)	Orthofix SRL	KWQ	Class II	2012-07-20
K121612	Elevate Prolapse Repair Systems-Apical Needle Passer Sheath Modification	American Medical Systems, Inc.	OTP	Class III	2012-07-20
K121517	Versavue Enterprise Suite	iCAD, Inc.	LLZ	Class II	2012-07-20
K121441	Cautery; Low Temperature (Fineadjustable Fine Tip, Elongated Fine Tip, Micro Fine Tip)	Apyx Medical Corporation	HQP	Class II	2012-07-20
K121416	Gmk Sphere	Medacta International SA	JWH	Class II	2012-07-20
K121159	Integra Camino Flex Ventricular Intracranial Pressure Monitoring Kit with Intrgra Camino Flex Adapter	Integra Lifescience Corportation	GWM	Class II	2012-07-20
K120849	Hybrid Arcticgel Pad	Medivance Inc.	DWJ	Class II	2012-07-20
K120839	Novacath Secure IV Catheter System-18G	Tangent Medical Technologies, Inc.	FOZ	Class II	2012-07-20
K120569	Gemore TENS System	Gemore Technology Co., Ltd.	GZJ	Class II	2012-07-20
K113498	Disposable Torque Device	Coeur, Inc.	DQX	Class II	2012-07-20
K113229	Ventrio Light Hernia Patch with Trm Antimicrobial Coating	C.R. Bard Inc	FTL	Class II	2012-07-20
K113162	Slidewiretm(trademark Pending)	Acme-Monaco Corp.	DQX	Class II	2012-07-20
K112389	Surgicase Connect, Surgicase Guide	Materialise N.V.	PBF	Class II	2012-07-20
K121868	Myosure Lite Tissue Removal Device (1 Pack), Myosure Lite Tissue Removal Device (3 Pack)	Hologic, Inc.	HIH	Class II	2012-07-19
K121572	Continuous Single Culture Complete	FUJIFILM Biosciences Inc.	MQL	Class II	2012-07-19
K121270	Bioject Needle-Free Injection Management System	Bioject Medical Technologies, Inc.	KZE	Class II	2012-07-19
K120970	Nitrile Powder Free Patient Examination Gloves, Colored (Blue)	Tangshan Zhonghong Pulin Plastic Co.,Ltd	LZA	Class I	2012-07-19
K120865	Rscribe Electrocardiograph	Mortara Instrument, Inc.	DPS	Class II	2012-07-19
K120834	Corpath 200 System	Corindus, Inc.	DXX	Class II	2012-07-19
K120598	Procare Monitor B40	GE Medical Systems China Co., Ltd.	MHX	Class II	2012-07-19
K120211	Sl-Plus Standard and Lateral Femoral Stem with Ti/ha Coating	Smith & Nephew, Inc.	LZO	Class II	2012-07-19
K113754	CFR Quant	University of Texas Medical School at Houston	KPS	Class II	2012-07-19
K113382	Ace Alt Reagent	Alfa Wassermann	CKA	Class I	2012-07-19
K112622	Handheld ECG Monitor	Beijing Choice Electronic Technololgy Co., Ltd.	DPS	Class II	2012-07-19
K112368	Capnostream20p with Ai/odi	Oridion Medical 1987 Ltd.	CCK	Class II	2012-07-19
K111406	Bever Reinforced Endotracheal Tube with Cuff (Oral/nasal), Bever Reinforced Endotracheal Tube without Cuff (Oral/nasal)	Hangzhou Bever Medical Devices Co., Ltd.	BTR	Class II	2012-07-19
K111401	Bever Endotracheal Tube, Bever Eva Endotracheal Tube	Hangzhou Bever Medical Devices Co., Ltd.	BTR	Class II	2012-07-19
K121777	U2 Acetabular Cup, Plasma Spray	United Orthopedic Corp.	LPH	Class II	2012-07-18
K121671	Pathfinder Nxt Minimally Invasive Pedicle Screw System	Zimmer Spine, Inc.	NKB	Class II	2012-07-18
K121638	St80i Stress Test System	Philips Health Care	DQK	Class II	2012-07-18
K121417	Xmcp, Hallux, Tarsx, Extremity Medical Screw System	Extremity Medical, LLC	HWC	Class II	2012-07-18
K121355	Wrist-Type Fully Automatic Digital Blood Pressure Monitor	Sejoy Electronics & Instruments Co., Ltd.	DXN	Class II	2012-07-18
K121349	Io Fix, Io Fix Plus, Carpalfix, Extremity Medical Screw and Washer	Extremity Medical, LLC	HWC	Class II	2012-07-18
K121323	Medicrea International Anterior Lumbar Plate	Medicrea International	KWQ	Class II	2012-07-18
K121319	Zio Patch	iRhythm Technologies, Inc.	DSH	Class II	2012-07-18
K121162	Polaris Q-Switch Ruby System	Sandstone Medical Technologies, LLC	GEX	Class II	2012-07-18
K121115	M.u.s.t Pedicle Screw System	Medacta International SA	KWP	Class II	2012-07-18
K120824	3.9Mm Reelx Stt Suture Anchor System	Stryker Corp.	MBI	Class II	2012-07-18
K120640	Insuflow Synergy Port	Lexion Medical, LLC.	HIF	Class II	2012-07-18
K120366	Intellivue Patient Monitor	Philips Medizinsysteme Boeblingen GmbH, Cardiac an	MHX	Class II	2012-07-18
K120325	Connected Care Mobile Application	WATERMARK MEDICAL Inc	DRG	Class II	2012-07-18
K121954	Nmi Microcatheter	Boston Scientific Corporation	DQO	Class II	2012-07-17