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 2026-10-22, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 551 of 3529

510(k) clearances, page 551 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K172922	Mmpc-4127F1	Barco N.V.	PZZ	Class II	2017-12-21
K172893	SafeSept Needle Free Transseptal Guidewire	Pressure Products Medical Device Manufacturing LLC	DRC	Class II	2017-12-21
K172623	NuVasive Navigation Instruments	Nu Vasive, Incorporated	OLO	Class II	2017-12-21
K172560	PREMIUM ONE Implant Systems	Sweden & Martina Inc	DZE	Class II	2017-12-21
K172467	OMNI ARC Anteverted Neck Hip Stem	Omni Life Science, Inc.	LZO	Class II	2017-12-21
K172448	Riptide Aspiration System	Micro Therapeutics, Inc. d/b/a ev3 Neurovascular	NRY	Class II	2017-12-21
K172330	Blustone Synergy Silica System	Blustone Synergy, LLC	MQP	Class II	2017-12-21
K172321	Shepard, Insemi-Cath, and Soft-Pass Coaxial - Cook Intrauterine Insemination Catheters	Cook Incorporated	MQF	Class II	2017-12-21
K172185	Tyber Medical PT Interbody Spacer System	Tyber Medical	ODP	Class II	2017-12-21
K171976	Sofia Strep A+ FIA, Sofia 2 Analyzer	Ortho-Clinical Diagnostics, Inc.	GTY	Class I	2017-12-21
K171877	Slm-1Er, Slm-2Er, Slm-3Er	Chongqing Kanghua Ruiming S&T Co., Ltd.	HJO	Class II	2017-12-21
K171848	FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO Corpectomy Spacers, SUSTAIN Spacers, COALITION Spacers, PATRIOT Lumbar Spacers, PATRIOT Cervical Spacers, ALTERA Spacers, RISE Spacers, CALIBER Spacers, ELSA Spacers, LATIS Spacers, MONUMENT Spacers, InterContinental Plate-Spacer, MAGNIFY Spacers, INDEPENDENCE Spacers	Globus Medical, Inc.	MAX	Class II	2017-12-21
K171530	Deltaven XiV Max, Deltaven XiV Max FF	Delta Med SpA	FOZ	Class II	2017-12-21
K171434	ROCCIA® MultiLIF	Silony Medical GmbH	MAX	Class II	2017-12-21
K171109	Praxiject 0.9% NaCl	Medxl, Inc.	NGT	Class II	2017-12-21
K171102	Ives MR Conditional Cup Electrode	Ives Egg Solutions	GXY	Class II	2017-12-21
K171043	Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric Catheters	MEDLINE INDUSTRIES, LP - Northfield	EYB	Class II	2017-12-21
K170028	FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EPI, RTU (Dako Onmis)	Agilent Technologies Denmark ApS	MYA	Class II	2017-12-21
K170005	FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294, Ready-to-Use (Dako Omnis)	Agilent Technologies Denmark ApS	MXZ	Class II	2017-12-21
DEN170024	AQUABEAM System	PROCEPT BioRobotics Corporation	PZP	Class II	2017-12-21
K173685	Peel-Away Introducer Set	Cook Incorporated	DYB	Class II	2017-12-20
K173662	speX Support Catheter	ReFlow Medical, Inc	DQY	Class II	2017-12-20
K173578	Biograph mCT Family of PET/CT Systems	Siemens Medical Solutions USA, Inc.	KPS	Class II	2017-12-20
K173555	Logiq E10	GE Healthcare	IYN	Class II	2017-12-20
K173349	Operio	Toul Meditech AB	ORC	Class II	2017-12-20
K173182	ProLift® Expandable System	Life Spine	MAX	Class II	2017-12-20
K173125	T2 STRATOSPHERE™ Expandable Corpectomy System	Medtronic Sofamor Danek	MQP	Class II	2017-12-20
K173115	COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and COALITION AGX® TPS	Globus Medical, Inc.	ODP	Class II	2017-12-20
K172989	Electric Breast Pump	Joytech Healthcare Co., Ltd.	HGX	Class II	2017-12-20
K172886	Breakaway Screw System	Paragon 28	HRS	Class II	2017-12-20
K172565	Advantage/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx Delivery Device (Curved & Halo), Obtryx II Delivery Device (Curved & Halo), Solyx SIS Delivery Device	Boston Scientific Corporation	PWJ	Class II	2017-12-20
K171866	Sentrant Introducer Sheath with Hydrophilic Coating	Medtronic, Inc.	DYB	Class II	2017-12-20
K171275	Micropuncture Introducer Set, Micropuncture Introducer Set with Push-Plus Design, Micropuncture Introducer Set with Silhouette Transitionless Design, Micropuncture Introducer Set with Silhouette Transitionless Design and Push-Plus Design	Cook Incorporated	DYB	Class II	2017-12-20
K170972	Apex Tibial Nailing System	Orthoxel	HSB	Class II	2017-12-20
K170950	Well-Root ST	Vericom Co., Ltd.	KIF	Class II	2017-12-20
K163550	Pobling MIITY 2	Habalan Med & Beauty Co.,Ltd	NFO	Class II	2017-12-20
K173696	TBL-ABI System	LD Technology LLC	JOM	Class II	2017-12-19
K173646	FS Ergo	Palodex Group Oy	MUH	Class II	2017-12-19
K173618	ACUSON AcuNav Volume Intracardiac Echocardiography Catheter	Siemens Medical Solutions USA, Inc.	OBJ	Class II	2017-12-19
K173600	MAGNETOM Amira	Siemens Medical Solutions USA, Inc.	LNH	Class II	2017-12-19
K173307	Liofilchem MIC Test Strip (MTS), Meropenem/vaborbactam 0.016/8 - 256/8 µg/mL	Liofilchem S.r.l.	JWY	Class II	2017-12-19
K173251	LumiCoil Platinum Fiducial Marker	Boston Scientific Corporation	IYE	Class II	2017-12-19
K173130	Reform® Midline Cortical Screw System	Precision Spine, Inc.	NKB	Class II	2017-12-19
K172986	Zmachine Synergy	Consolidated Research of Richmond, Inc. dba General Sleep Co	OLV	Class II	2017-12-19
K172982	SuperGrow 272, Ultimate 272	Super Grow Lasers	OAP	Class II	2017-12-19
K172944	VITEK 2 AST-GN Ceftazidime/Avibactam <=0.12 – >=16 µg/mL	bioMerieux, Inc.	LON	Class II	2017-12-19
K172861	Digital thermometer(with disposable thermometer cover)	Hangzhou Hua'an Medical & Health Instruments Co.	FLL	Class II	2017-12-19
K172743	Natus VikingQuest	Medtronic, Inc.	IKN	Class II	2017-12-19
K172677	Advantage Plus Pass-Thru	Medivators Inc	FEB	Class II	2017-12-19
K171889	Reusable Blood Pressure Cuff	Suzhou Minhua Medical Apparatus Supplies Co., Ltd.	DXQ	Class II	2017-12-19