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 2026-10-19, 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 507 of 3529

510(k) clearances, page 507 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K180933	DenTek Ultimate Dental Guard	MedTech Products, Inc.	OBR	Unclassified	2018-09-17
K173871	CalliSpheres Embolic Microspheres, 8Spheres Embolic Microspheres	Suzhou Hengrui Callisyn Biomedical Co., Ltd.	NAJ	Class II	2018-09-17
K181102	ThermaCare Quick Therapy TENS	Pfizer Inc	NUH	Class II	2018-09-15
K182223	Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A	Canon Medical Systems USA, Inc.	JAK	Class II	2018-09-14
K182214	DizzyDoctor System 1.0.0	Dizzydoctor Systems, LLC	GWN	Class II	2018-09-14
K182213	QT Ultrasound Breast Scanner - 1	Qt Ultrasound, LLC	IYO	Class II	2018-09-14
K181874	MX40 Mobile Digital X-ray System	Huestis Machine Corp.	IZL	Class II	2018-09-14
K181598	Prime E-CLASS XLPE Liner	Microport Orthopedics Inc.	LZO	Class II	2018-09-14
K180875	Poly Rejuv	Medtek Skincare, LLC	OHS	Class II	2018-09-14
K180871	Portable Nebulizer	Microbase Technology Corp.	CAF	Class II	2018-09-14
K180369	Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe)	Relievant Medsystems	GXI	Class II	2018-09-14
K180182	Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access Catheter	Cook Incorporated	EYB	Class II	2018-09-14
K173926	DORADOnova MR3T	LAP GmbH Laser Applikationen	IYE	Class II	2018-09-14
K173910	Impress SFS System	Cable Fix Medical, LLC	JDQ	Class II	2018-09-14
K173827	LightScalpel	Lightscalpel Inc	GEX	Class II	2018-09-14
K173676	A-Fit	Hironic Co., Ltd.	GEX	Class II	2018-09-14
K182275	Seal Single Use Biopsy Valve	Boston Scientific Corporation	OCX	Class II	2018-09-13
K182206	RiX70 DC	Trident SRL	EHD	Class II	2018-09-13
K181889	MTS Penicillin 0.002- 32 µg/mL	Liofilchem S.r.l.	JWY	Class II	2018-09-13
K181821	MOSS VRS Spinal System	BIEDERMANN MOTECH GmbH & Co. KG	NKB	Class II	2018-09-13
K181594	Spectralis HRA+OCT and variants with OCT Angiography Module	Heidelberg Engineering GmbH	OBO	Class II	2018-09-13
K181576	Planmeca Viso	Planmeca Oy	OAS	Class II	2018-09-13
K181241	KLS Martin Individual Patient Solutions (IPS) Planning System	KLS-Martin L.P.	DZJ	Class II	2018-09-13
K181236	HySil Impression Materials	OSSTEM Implant Co., Ltd.	ELW	Class II	2018-09-13
K181000	SelectFlex 072 Neurovascular Access System	Q'Apel	DQY	Class II	2018-09-13
K180215	DYNA-LINK ELITE Stand-Alone Anterior Lumbar System	Life Spine	OVD	Class II	2018-09-13
K180053	Sof-Flex Ureteral Stent Set	Cook Incorporated	FAD	Class II	2018-09-13
K173933	Sorrento Bioglass Bone Graft Substitute	Xenco Medical LLC	MQV	Class II	2018-09-13
K172450	TENS device-HeadaTerm, eEspress	Wat Medical Technology (Ningbo) Co., Ltd.	PCC	Class II	2018-09-13
K181748	Magnesium	Abbott Medical	JGJ	Class I	2018-09-12
K181255	PRODENSE Bone Graft Substitute	Wrightmedicaltechnologyinc	MQV	Class II	2018-09-12
K173424	BioSphere Flex	Synergy Biomedical	MQV	Class II	2018-09-12
K182232	Octane Mechanical Thrombectomy System	Vascular Solutions LLC	QEZ	Class II	2018-09-11
K182226	AirStrip RPM InvisionHeart Adapter	AirStrip Technologies, Inc.	MWI	Class II	2018-09-11
K182196	Cardiart Electronic Stethoscope Model DS101 Omni-Steth Electronic Stethoscope Model Omni-Steth	Imediplus, Inc.	DQD	Class II	2018-09-11
K181655	Renovis S180 Lateral Lumbar Interbody Fusion System	Renovis Surgical Technologies, LLC	MAX	Class II	2018-09-11
K181568	IPL Salon Hair Reduction System	Medical Device Branch of Zhangzhou Easepal Industrial Co.,Lt	OHT	Class II	2018-09-11
K181504	Stryker Pediatric Mandibular Distractor 2	Stryker Corp.	MQN	Class II	2018-09-11
K181380	LnK Lumbar Interbody Fusion Cage System	L&K Biomed Co.,Ltd.	MAX	Class II	2018-09-11
K173822	Anchor Tissue Retrieval System by CONMED	ConMed Corporation	GCJ	Class II	2018-09-11
K171532	TruBase S	TruAbutment Inc.	NHA	Class II	2018-09-11
DEN180044	ECG App	Apple, Inc.	QDA	Class II	2018-09-11
DEN180042	Irregular Rhythm Notification Feature	Apple, Inc.	QDB	Class II	2018-09-11
K182055	SECULOK™ ACP System	CG MedTech Co., Ltd.	KWQ	Class II	2018-09-10
K181455	ProSun sunlamp products, Luxura sunlamp products	J&T Health and Wellness LLC	LEJ	Class II	2018-09-10
K181415	XIDF - AWS801, Angio Workstation (Alphenix Workstation), V8.0	Canon Medical Systems Corporation	OWB	Class II	2018-09-10
K181211	Human Tecar HCR 1002	Unibell SRL	PBX	Class II	2018-09-10
K181078	The Sex Gel	Necessaire, Inc	NUC	Class II	2018-09-10
K173941	IntelliSpace Perinatal Rev.K.00	Philips Medizin Systeme Boeblingen GmbH	HGM	Class II	2018-09-10
K182263	RetCam 3 ; RetCam Shuttle ; RetCam Portable	Natus Medical Incorporated	HKI	Class II	2018-09-07