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 1162 of 3531

510(k) clearances, page 1162 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K072688	Lifechoice Oxygen Concentrator, Model Oxy1000	International Biophysics Corp.	CAW	Class II	2008-01-11
K072385	Heartevent, Model at	Diagnostic Devices, Inc.	DXH	Class II	2008-01-11
K071939	Hydrocoil Embolic Systems (Hes)	Terumo Cardiovascular Systems Corporation	KRD	Class II	2008-01-11
K071788	Aviator Insulin Pump	Abbott Medical	LZG	Class II	2008-01-11
K071608	A&j Poca01 Oxygen Concentrator	Zhongshan A&j Medical Equipment Co., Ltd.	CAW	Class II	2008-01-11
K073632	Intuition, Model 0170	Arcoma AB	KPR	Class II	2008-01-10
K073152	Pc-180 / Prince 180 Easy ECG Monitor	Shenzhen Creative Industry Co., Ltd	DSH	Class II	2008-01-10
K073130	Spy Fluorescent Imaging System	Novadaq Technologies ULC	IZI	Class II	2008-01-10
K073088	Spy Fluorescent Imaging System	Novadaq Technologies ULC	IZI	Class II	2008-01-10
K073068	Accin Hip System	Accelerated Innovation, LLC	LPH	Class II	2008-01-10
K072925	Candela-Inolase Serenity Pro Psf System	Inolase, Ltd.	GEX	Class II	2008-01-10
K072888	Revelation and Linear Hip Stems and Fmp Acetabular Shells (Spiked, Hemispherical and Flared)	Encore Medical, LP	LPH	Class II	2008-01-10
K072871	Ms System (Provisional)	OSSTEM Implant Co., Ltd.	DZE	Class II	2008-01-10
K072703	Pioneer Slimfuse Anterior Cervical Plating System	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)	KWQ	Class II	2008-01-10
K072434	Synthes Oc Fusion and Synapse Systems	Synthes Spine Co.Lp	MNI	Class II	2008-01-10
K072417	Smith & Nephew Mis Hip Stem	Smith & Nephew, Inc.	LPH	Class II	2008-01-10
K072332	Vari-Lase Wire Fiber	Vascular Solutions LLC	GEX	Class II	2008-01-10
K071782	Micromed Brain Spy Plus, Embia Titanium Devices	MicroMed, LLC	OLV	Class II	2008-01-10
K073687	Habib Laparoscopic Hexablate	Emcision, Ltd.	GEI	Class II	2008-01-09
K073505	Modification to Valeo Vbr	Amedica Corp.	MQP	Class II	2008-01-09
K073495	Tissuelink Aquamantys Malleable Bipolar Sealer with Light	Medtronic Navigation, Inc	GEI	Class II	2008-01-09
K073479	Kinetic-Sl Anterior Cervical Plate System	Life Spine	KWQ	Class II	2008-01-09
K073472	Vaccess Pta Balloon Dilatation Catheter	C.R. Bard Inc	LIT	Class II	2008-01-09
K073296	Tempxn28	3M Espe AG Dental Products	EBG	Class II	2008-01-09
K073169	Scimage Picomenterprise	Scimage, Inc.	LLZ	Class II	2008-01-09
K073082	Cps Courier Guidewire	Brivant, Ltd.	DQX	Class II	2008-01-09
K072963	Depuy Pinnacle Altrx Acetabular Liners	Depuy Orthopaedics Inc.	LPH	Class II	2008-01-09
K072881	NEOMED Enteral FEEDING TUBE	Halyard Health	FPD	Class II	2008-01-09
K072834	Sibel Sa Vascular Clamp	Surgical Instruments Belgium SA	DXC	Class II	2008-01-09
K072566	Hanger Cranial Band	Hanger Prosthetics & Orthotics, Inc.	OAN	Class II	2008-01-09
K072432	F3 Fractured Finger Fixator, Sterile (Model: Fcs 400) and Non Sterile	Hand Biomechanics Lab Inc	JEC	Class II	2008-01-09
K072367	Repiphysis Limb Salvage Proximal Femur and Total Femur	Wrightmedicaltechnologyinc	KRO	Class II	2008-01-09
K072265	Progenix Dmb Putty	Medtronic Sofamor Danek	MQV	Class II	2008-01-09
K071291	Echoview / Shimasonic Diagnostic Ultrasound System, Model Sdu-1100	Shimadzu Medical Systems	ITX	Class II	2008-01-09
K071289	Echoview / Shimasonic Diagnostic Ultrasound System, Model Sdu-1200Pro	Shimadzu Medical Systems	ITX	Class II	2008-01-09
K071287	Echoview / Shimasonic Diagnostic Ultrasound Device, Model Sdu-2200Pro	Shimadzu Medical Systems	ITX	Class II	2008-01-09
K070945	Asahi Ptca Guide Wire	Asahi Intecc Co., Ltd.	DQX	Class II	2008-01-09
K072581	Pm-60 Pulse Oximeter	Shenzhen Mindray Bio-Medical Electronics Co.,LTD	DQA	Class II	2008-01-08
K072067	N95 Surgical Respirator, Type Ap0018 and Ap0028	Shuenn Bao Shing Corp.	MSH	Class II	2008-01-08
K073535	Biofoam Bone Wedge	Wrightmedicaltechnologyinc	HRS	Class II	2008-01-07
K073481	Threvo Anchor, Disposable Driver, Hi-Fi Sutures	Conmed Linvatec	MBI	Class II	2008-01-07
K073306	Xoranconnect	Xoran Technologies, LLC	LLZ	Class II	2008-01-07
K073218	Mta Advanced Material	Dentsply Interntional	KIF	Class II	2008-01-07
K072953	Redline Alcohol Breath Tester	Redline Products (Pty), Ltd.	DJZ	Class I	2008-01-07
K072575	Triathlon Screw-Fixation Tibial Baseplate	Stryker Orthopaedics	MBH	Class II	2008-01-07
K072331	Radiancy Mistral Device	Radiancy (Israel), Ltd.	GEX	Class II	2008-01-07
K072292	Negavent Plus Pegaso Cough, Model: Da-3 Plus	Dima Italia SRL	NHJ	Class II	2008-01-07
K072121	Trabecular Metal Acetabular Revision System Cemented Contrained Liner	Zimmer GmbH	KWZ	Class II	2008-01-07
K073480	Life Spine Cross Connector	Life Spine	NKB	Class II	2008-01-04
K073336	Codman Craniotomy Kit, Models 26-1229, 26-1230, 26-1231	Cerenovus, Inc.	HBF	Class II	2008-01-04