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 2026-10-15, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,969 of the 176,366 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	2,569

176,366 records, page 458 of 3528

510(k) clearances, page 458 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K191315	Remington Medical, Inc. Automatic Cutting Needle (NAC)	Remington Medical	KNW	Class II	2019-07-12
K191272	Wearable Device, Wearable Package	Current Health Inc	MSX	Class II	2019-07-12
K191259	Stryker CrossFlow Integrated Arthroscopy Pump	Stryker Corp.	HRX	Class II	2019-07-12
K191050	MAGNETOM Aera and MAGNETOM Skyra with Software syngo MR E11E with Ischemic Heart Disease (IHD) Workflow	Siemens Medical Solutions USA, Inc.	LNH	Class II	2019-07-12
K190999	SureForm 45 Curved Tip, SureForm 45 Gray Reload	Intuitive Surgical, Inc.	NAY	Class II	2019-07-12
K190976	Radial Medical Compression System	Radial Medical, Inc.	JOW	Class II	2019-07-12
K190972	Ambu aScope 4 RhinoLaryngo Intervention	Ambu A/S	EOB	Class II	2019-07-12
K190457	VERITON CT whole body SPECT/CT system	Spectrum Dynamics Medical Inc.	KPS	Class II	2019-07-12
K183473	AMSafe(R) Pre-Filled Normal Saline Flush Syringe	Amsino International, Inc.	NGT	Class II	2019-07-12
K182930	PerioLase Nd:YAG Pulsed Dental Laser System	Millennium Dental Technologies, Inc.	GEX	Class II	2019-07-12
K182714	Novidia Bulk Fill Flow Composite	Nobio, Ltd.	EBF	Class II	2019-07-12
K182091	Osstem Abutment System	OSSTEM Implant Co., Ltd.	NHA	Class II	2019-07-12
K191594	Nuvis Battery Arthroscope	Integrated Endoscopy, Inc.	HRX	Class II	2019-07-11
K191579	Voyant System	Viseon, Inc.	HRX	Class II	2019-07-11
K191534	ID NOW Influenza A & B 2	Abbott Diagnostics Scarborough, Inc.	OCC	Class II	2019-07-11
K191482	Senhance Surgical System	Asensus Surgical, Inc.	NAY	Class II	2019-07-11
K191138	AeroForm Tissue Expander, Smooth	Airxpanders, Inc.	PQN	Class II	2019-07-11
K190960	Nalu Lead Blank (50cm)	Boston Scientific Neuromodulation Corporation	GZB	Class II	2019-07-11
K190718	Zygomatic Implants	JJGC Industria e Comercio de Materiais Dentarios SA	DZE	Class II	2019-07-11
K190694	Unifi Workspace v1.0.0	Hologic, Inc.	LLZ	Class II	2019-07-11
K190229	Stryker PEEK Customized Cranial Implant Kit	Stryker Corp.	GWO	Class II	2019-07-11
K182854	GC FujiCEM 2 (Improved)	GC America Inc.	EMA	Class II	2019-07-11
K181457	EndoStream(TM)	Partnership Medical Limited	OCX	Class II	2019-07-11
K181418	ScopeFlow Pure(TM)	Partnership Medical Limited	OCX	Class II	2019-07-11
K191592	CalprestNG, EasyCal	Eurospital S.p.A.	NXO	Class II	2019-07-10
K191589	Calprest, EasyCal	Eurospital S.p.A.	NXO	Class II	2019-07-10
K191557	CentriMag Acute Circulatory Support System	Thoratec Corporation (Now Part of Abbott)	DWA	Class II	2019-07-10
K191541	Vave Personal Ultrasound System	Vave Health Inc	IYO	Class II	2019-07-10
K191408	Nexxt Matrixx System	Nexxt Spine LLC	MAX	Class II	2019-07-10
K191045	Salvo™ Spine System	Spine Wave Inc	NKB	Class II	2019-07-10
K190818	Microlife Upper Arm Automatic Digital Blood Pressure Monitor	Microlife Intellectual Property GmbH	DXN	Class II	2019-07-10
K190801	PressOn Electrode Headset	Rhythmlink International, LLC	GXZ	Class II	2019-07-10
K190620	SpeediCath Flex Coude Pro	MEDLINE INDUSTRIES, LP - Northfield	GBM	Class II	2019-07-10
K190528	MariGen Wound Extra	Kerecis Limited	KGN	Unclassified	2019-07-10
K190137	Identify	Varian Medical Systems, Inc.	IYE	Class II	2019-07-10
K190107	VeriSplint	Whip-Mix Corp.	MQC	Unclassified	2019-07-10
K190011	Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)	Shenzhen Mindray Bio-Medical Electronics Co.,LTD	MHX	Class II	2019-07-10
K183322	physIQ Heart Rhythm and Respiratory Module	Physiq, Inc.	DPS	Class II	2019-07-10
K183243	Velofix TLIF Cage	CG MedTech Co., Ltd.	MAX	Class II	2019-07-10
K183079	Conometric Abutments	Dentsply Sirona Inc	NHA	Class II	2019-07-10
K183041	Full Digital Colour Doppler Ultrasonic Diagnostic System	Wuhan Zoncare Bio-medical Electronics Co., Ltd.	IYN	Class II	2019-07-10
K182875	DeepCT	Deep01 Limited	QAS	Class II	2019-07-10
K182829	Scepter Mini Occlusion Balloon Catheter	Terumo Cardiovascular Systems Corporation	DQY	Class II	2019-07-10
K182471	Scooter	Tianjin Kepler Vehicle Industry Co.,Ltd	INI	Class II	2019-07-10
K191252	Gem FlowCoupler System	Baxter/ Synovis Micro Companies Alliance, Inc.	MVR	Class II	2019-07-09
K191162	EpiLaze Multi-wavelength Laser	Rohrer Aesthetics, Inc.	GEX	Class II	2019-07-09
K190969	ENDOSCOPE REPROCESSOR OER-Elite	Olympus Medical Systems Corp.	FEB	Class II	2019-07-09
K183623	LifeSPARC Pump, LifeSPARC Controller	Cardiacassist, Inc.	KFM	Class II	2019-07-09
K182163	Shear Stress Therapeutics SST 3000	Shear Stress Therapeutics, LLC	IPF	Class II	2019-07-09
K181957	Heat Sealing Sterilization Pouch Flat, Heat Sealing Sterilization Pouch Gusseted, Heat Sealing Sterilization Pouch Roll Flat, Heat Sealing Sterilization Pouch Roll Gusseted	Tianchang Jiarui Packaging Material Co., Ltd.	FRG	Class II	2019-07-09