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 2026-10-26, 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 732 of 3530

510(k) clearances, page 732 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K142209	Pulse oximeter NBM-200	Orsense Ltd	DQA	Class II	2015-01-16
K141921	Hivox Spopad Ems	Hivox Biotek Inc.	NGX	Class II	2015-01-16
K141789	Plum 360 Infusion System with Hospira Mednet, Smart Card Plug N Play Ce 3.0 Module for Plum a+ Infusion System Upgrade	Abbott Medical	FRN	Class II	2015-01-16
K141608	Collagen Dura Membrane	Collagen Matrix, Inc	GXQ	Class II	2015-01-16
K141561	Vm Pacs with Vm Medical Workstation	Visual Medica	LLZ	Class II	2015-01-16
K141379	Victus Femtosecond Laser Platform	Technolas Perfect Vision GmbH	OOE	Class II	2015-01-16
K141206	Edwards Lifesciences Thruport Knotting System	Edwards Lifesciences LLC	GAW	Class II	2015-01-16
K140580	Revolution Fullface Mask	Respironics Inc. (dba Philips Respironics)	BZD	Class II	2015-01-16
K133239	Zoll E Series	ZOLL Medical Corporation	MKJ	Class III	2015-01-16
K131950	Angel Tip Safety Intravascular Needle Set	Summit International Medical Technologies, Inc.	FIE	Class II	2015-01-16
K143625	truFreeze System	CSA Medical	GEH	Class II	2015-01-15
K143587	ChoICE Guide Wire, Mailman Guide Wire, Luge Guide Wire, ChoICE PT Guide Wire, PT Graphix Wire	Boston Scientific Corporation	DQX	Class II	2015-01-15
K143311	Pre-vacuum Tabletop Autoclave	Tuttnauer USA Co. Ltd.	FLE	Class II	2015-01-15
K143040	Exilis XP	BTL Industries, Inc	PBX	Class II	2015-01-15
K143007	Erchonia Zerona Z6 OTC	Erchonia Corporation	OLI	Class II	2015-01-15
K142935	CareEvent	Philips North America LLC	MSX	Class II	2015-01-15
K142828	osteoSPAN Morpheus	Biogennix, LLC	MQV	Class II	2015-01-15
K142741	OASYS System	Stryker Corp.	KWP	Class II	2015-01-15
K142703	Powder-free PVC Vinyl Exam Gloves	Hebei Grandeast Plastic Products Co Ltd	LYZ	Class I	2015-01-15
K142675	CI../..X liner for NOVAE Dual Mobility Acetabular Cup	Serf	LZO	Class II	2015-01-15
K142622	IV Administration	Abbott Medical	FPA	Class II	2015-01-15
K142475	Evs 4343	DRTECH Corporation	MQB	Class II	2015-01-15
K142144	Disposable Injection Needle	Wilson Instruments (Shanghai) Company Limited	FBK	Class II	2015-01-15
K141549	SImmetry Sacroiliac Joint Fusion System	Zyga Technology, Inc.	OUR	Class II	2015-01-15
K141224	Jiuyuan Powder-Free Yellow Synthetic Vinyl Patient Examination Gloves	Shijiazhunag Jiuyuan Plastic Co., Ltd.	LYZ	Class I	2015-01-15
K141187	Impix Alif S/a	Medicrea International	OVD	Class II	2015-01-15
K141070	Super Sheath	Togo Medikit Co., Ltd.	DRE	Class II	2015-01-15
K140957	Genasis Hipath Ihc Family	Applied Spectral Imaging, Ltd.	NQN	Class II	2015-01-15
K140471	Pro X OTC 5	La Lumiere, LLC	OHS	Class II	2015-01-15
K132172	Neonatalie Resuscitator	Laerdal Medical a/S	BTM	Class II	2015-01-15
K143549	Vivorte Trabexus	Vivorte, Inc.	MQV	Class II	2015-01-14
K143547	Vivorte Trabexus EB	Vivorte, Inc.	MBP	Class II	2015-01-14
K143504	IMMULITE 2000 Albumin Calibration Verification Material, IMMULITE 2000 Myoglobin Calibration Verification Material	Siemens Healthcare Diagnostics Inc.	JJX	Class I	2015-01-14
K143493	SignosRT Bladder Ultrasound System	Signostics Limited	IYO	Class II	2015-01-14
K143412	ADROIT Guiding Catheter	Cordis US Corp.	DQY	Class II	2015-01-14
K143068	Medical Monofilament Sensory Screening Toool	Medical Monofilament Manufacturing	GXB	Class I	2015-01-14
K142816	AbbVie J	AbbVie Inc	KNT	Class II	2015-01-14
K142793	AbbVie PEG	AbbVie Inc	KNT	Class II	2015-01-14
K142792	AbbVie NJ	AbbVie Inc	KNT	Class II	2015-01-14
K142553	UNIEVER Disposable Epidural Anesthesia Needle, UNIEVER Disposable Nerve Blocked Needle	Unisis Corp	BSP	Class II	2015-01-14
K142368	Noblus Diagnostic Ultrasound Scanner	Hitachi Aloka Medical, Ltd.	IYN	Class II	2015-01-14
K142335	RapidVac Smoke Evacuator System	Medtronic, Inc.	FYD	Class II	2015-01-14
K143624	Headless Compression Screw System	Skeletal Dynamics, Inc	HWC	Class II	2015-01-13
K143535	CR3 Keyless Split Sample Cup Secobarbital- Methadone	Guangzhou Wondfo Biotech Co., Ltd.	DIS	Class II	2015-01-13
K143393	Triathlon Tritanium Cone Augments	Stryker Orthopaedics	MBH	Class II	2015-01-13
K142952	InMode Diolaze Device	Inmode MD, Ltd.	GEX	Class II	2015-01-13
K142948	BIOSURE REGENESORB interference Screw	Smith & Nephew, Inc.	MAI	Class II	2015-01-13
K142939	Revolution Spinal Fixation System	Intelligent Implant Systems, LLC	NKB	Class II	2015-01-13
K142759	PK Cutting Forceps for ESG-400 Workstation	Gyrus ACMI, Inc.	GEI	Class II	2015-01-13
K142722	3B Laser 500, 3B Laser 200, LA-X P 500, LA-X P 200	Livetec GmbH	ILY	Class II	2015-01-13