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 613 of 3529

510(k) clearances, page 613 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K151857	Love Alchemy's Love Lotion	Love Alchemy LLC	NUC	Class II	2017-01-09
K163492	Oracle EUS Balloon; Oracle EUS latex balloon - Olympus Radial; Oracle EUS latex balloon - Olympus Linear; Oracle EUS latex balloon - Fujinon Radial; Oracle EUS latex balloon - Fujinon Linear	United States Endoscopy Group, Inc.	FDF	Class II	2017-01-06
K163490	StatStrip Xpress 2 Glucose Hospital Meter System	Nova Biomedical Corporation	PZI	Class II	2017-01-06
K163457	NeuraGen 3D Nerve Guide Matrix	Integra LifeSciences Corporation	JXI	Class II	2017-01-06
K163456	DuraGen Secure Dural Regeneration Matrix	Integra LifeSciences Corporation	GXQ	Class II	2017-01-06
K163444	Spectre guidewire	Vascular Solutions LLC	DQX	Class II	2017-01-06
K163142	SpeedStitch Suture Passer; SpeedStitch Suture Cartridges, White Suture, Blue Cobraid, Black Cobraid, Mixed Pack; SpeedStitch Needle Loader and Unloader	ArthroCare Corporation	GAT	Class II	2017-01-06
K163141	NAMIC ClearaCIL Contrast Injection Lines	Boston Scientific Corporation	DQO	Class II	2017-01-06
K163116	Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3	Philips Medical Systems Nederland B.V.	LNH	Class II	2017-01-06
K163013	Quantib Brain 1.2	Quantib B.V.	LLZ	Class II	2017-01-06
K162969	LIAISON® CMV IgG and LIAISON® CMV IgG Serum Control Set	Diasorin Inc.	LFZ	Class II	2017-01-06
K162946	8ch Knee-Foot SPEEDER	Quality Electrodynamics	MOS	Class II	2017-01-06
K162931	Ingenia 1.5T CX and Ingenia 3.0T CX R5.3	Philips Medical Systems Nederland B.V.	LNH	Class II	2017-01-06
K162887	PrismaSATE	Baxter Healthcare Corporation	KPO	Class II	2017-01-06
K162490	Disc-FX System	Elliquence LLC	GEI	Class II	2017-01-06
K162253	Trapper Exchange Device	Creganna Medical Aslo Business AS Cregganna Tactx Medical	DQY	Class II	2017-01-06
K162181	Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set	Cardiacassist, Inc.	DRE	Class II	2017-01-06
K162086	MultiStim ECO	Pajunk GmbH Medizintechnologie	BXN	Class II	2017-01-06
K161504	Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray	Cook Incorporated	MPB	Class II	2017-01-06
K161463	SureClip(TM) Repositionable Hemostasis Clip	Micro-Tech (Nanjing) Co., Ltd.	PKL	Class II	2017-01-06
K161036	Hospira Extension Set, Hospira Primary Set	Abbott Medical	FPA	Class II	2017-01-06
K163454	ECHELON FLEX 45mm Powered Plus Articulating Endoscopic Linear Cutters, ECHELON ENDOPATH Endoscopic Linear Cutter Reloads, 45mm	Ethicon Endo-Surgery Inc	GDW	Class II	2017-01-05
K163253	Arterys Cardio DL	Arterys Inc.	LLZ	Class II	2017-01-05
K163114	Sapphire II PRO	Orbusneich Medical, Inc.	LOX	Class II	2017-01-05
K162961	LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set; LIAISON® EBNA IgG and LIAISON® EBNA IgG Serum Control Set	Diasorin Inc.	LSE	Class I	2017-01-05
K162763	Vevazz LED Heat Lamp	Vevazz, LLC	ILY	Class II	2017-01-05
K162705	VALIDATE® D-Dimer Calibration Verification/ Linearity Test Kit	Maine Standards Co.	GGN	Class II	2017-01-05
K162563	YOGA Microcatheter	Cerenovus, Inc.	DQY	Class II	2017-01-05
K162561	Turbo-Power (2.0mm) Laser Atherectomy Catheters	Spectranetics Corp.	MCW	Class II	2017-01-05
K162146	Brightway Brand Nitrile Examination Gloves, Powder Free (Lavender)	Brightway Holdings Sdn. Bhd.	LZA	Class I	2017-01-05
K162064	CrossBay IVF Embryo Transfer Catheter Set	Crossbay Medical	MQF	Class II	2017-01-05
K161641	LOSPA IS ACP System	Corentec Co., Ltd.	KWQ	Class II	2017-01-05
K161637	Poseidon OCT Spinal Fixation System	Medyssey USA	NKG	Class II	2017-01-05
K161536	EasyOne Air Spirometer	NDD Medizintechnik AG	BZG	Class II	2017-01-05
K161202	C2 Cryoballoon Ablation System	PENTAX of America, Inc.	GEH	Class II	2017-01-05
K160536	Chaorum Implant System	Medimecca Co Ltd	DZE	Class II	2017-01-05
K160469	Agnes	Gowoonsesang Cosmetics Co., Ltd.	GEI	Class II	2017-01-05
K163429	B6	Beijing East Whale Imaging Technology Co., Ltd.	OXO	Class II	2017-01-04
K163424	AquaShield System - PENTAX, AquaShield System CO2 - PENTAX, AquaShield System CO2 - FUJINON	United State Endoscopy Group, Inc.	FEQ	Class II	2017-01-04
K163410	DigitalDiagnost C50	Philips Healthcare (Suzhou) Co., Ltd.	KPR	Class II	2017-01-04
K163396	ACUSON P500 Ultrasound System	Siemens Medical Solutions USA, Inc.	IYN	Class II	2017-01-04
K162959	LIAISON® EA IgG and LIAISON® EA IgG Serum Control Set	Diasorin Inc.	LSE	Class I	2017-01-04
K162770	Relign System	Relign Corporation	GEI	Class II	2017-01-04
K162234	Truscope Ultra Patient Monitor	Guangdong Biolight Meditech Co., Ltd	MWI	Class II	2017-01-04
K162223	Aveo 1-DAY Aspheric Soft Contact Lens (omafilcon A)	Supervision Optimax Sdn Bhd	LPL	Class II	2017-01-04
K161270	CephSimulation	Anatomage, Inc.	LLZ	Class II	2017-01-04
K153184	Caremed Reusable & Disposable SPO2 Sensors	Shenzhen Caremed Medical Technology Co.,Ltd.	DQA	Class II	2017-01-04
K163427	X3 Exp/X3/X3 Pro/X1 Pro/X1 Digital Color Doppler Ultrasound System	Sonoscape Medical Corp.	IYN	Class II	2017-01-03
K163421	syngo.via MI Workflows	Siemens Medical Solutions USA, Inc.	LLZ	Class II	2017-01-03
K163408	Isolator Multifunctional Linear Pen	AtriCure, Inc.	OCL	Class II	2017-01-03