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 312 of 3528

510(k) clearances, page 312 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K212730	BellaTek Encode Emergence Healing Abutments	ZimVie US Corp LLC	NHA	Class II	2021-12-21
K212690	qXR-BT	Qure.ai Technologies Inc	QIH	Class II	2021-12-21
K212613	Powder Free Nitrile Examination Gloves, Non-sterile,Tested For Use with Chemotherapy Drugs and Opioid Fentanyl Citrate (Blue)	Koon Seng Sdn Bhd	LZA	Class I	2021-12-21
K212266	FIX-C PEEK Anterior Cervical Interbody System	Jeil Medical Corporation	ODP	Class II	2021-12-21
K212155	TheraFace LED	Theragun, Inc.	OHS	Class II	2021-12-21
K211918	iCOquit® Smokerlyzer®	Bedfont Scientific Ltd.	CCJ	Class II	2021-12-21
K211109	N1 TiUltra TCC Implant System	Nobel Biocare Services AG	DZE	Class II	2021-12-21
K211086	The Progen™ Trochanteric Nail System	Ortho Development Corp.	HSB	Class II	2021-12-21
K211078	Progreat Lambda	Terumo Clinical Supply Co., Ltd.	DQO	Class II	2021-12-21
K210968	reVive Light Therapy Essentials	LED Technologies, Inc.	OLP	Class II	2021-12-21
K210670	Bu-Cad	Taihao Medical, Inc.	QDQ	Class II	2021-12-21
K210331	CardiaMend Pericardial and Epicardial Reconstruction Matrix	Helios Cardio Inc.	PSQ	Class II	2021-12-21
K210099	Meticuly Patient-Specific Titanium Mesh Implant	Meticuly Co., Ltd.	GXN	Class II	2021-12-21
K203660	TRI-matrix Implant Line	Tri Dental Implants Int. AG	DZE	Class II	2021-12-21
K203343	Wesper Lab	Wesper, Inc.	MNR	Class II	2021-12-21
DEN210024	CavaClear Laser Sheath	Spectranetics Corp.	QRJ	Class II	2021-12-21
K213531	TR BAND Radial Compression Device	Terumo Medical Corp.	DXC	Class II	2021-12-20
K213275	EchoGo Core (2.0)	Ultromics, Ltd.	QIH	Class II	2021-12-20
K213076	AspenMed+	Aspen Glove Sdn. Bhd.	LZC	Class I	2021-12-20
K213031	Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Start-Up Kit, Coolgard 3000 Console, Thermogard XP Console	ZOLL Circulation, Inc.	NCX	Class II	2021-12-20
K212859	First Relief	Dyansys, Inc.	NHI	Class II	2021-12-20
K212776	Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled	Innovative Health, LLC.	NLG	Class II	2021-12-20
K212715	Vy Spine ClariVy Cervical IBF System	VY Spine, LLC	ODP	Class II	2021-12-20
K212492	Frax 1940 for Nordlys and Frax Pro	Candela Corporation	GEX	Class II	2021-12-20
K211865	Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)	Liao Ning Shangwei Medical Products Co., Ltd	LYZ	Class I	2021-12-20
K211847	AdVance XP Male Sling System	Boston Scientific Corporation	OTM	Class II	2021-12-20
K211842	Servator M SALF Solution	S.A.L.F. SpA	KDL	Class II	2021-12-20
K211750	Disposable Surgical Face Mask, Disposable Surgical Face Mask (Sterile)	National Bridge Industrial (S.Z.) Co., Ltd.	FXX	Class II	2021-12-20
K211521	3M Veraflo Cleanse Choice Complete Dressing Kit (Medium Dressing Kit: VFCCC05MD, Large Dressing Kit: VFCCC05LG)	3M Healthcare Business Group	OMP	Class II	2021-12-20
K211185	IPL Home Use Hair Removal Device	Shenzhen Beauty Every Moment Intelligent Electric Co., Ltd.	OHT	Class II	2021-12-20
K203741	Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Cefiderocol in the dilution range of 0.03-64 ug/ml	Thermo Fisher Scientific Oy	JWY	Class II	2021-12-20
K203468	TCAT TKA Instrument Tray	Think Surgical Inc.	KCT	Class II	2021-12-20
K202568	Mpact® 3D Metal Implants - DMLS Technology	Medacta International SA	LPH	Class II	2021-12-20
K210559	ATOZ Mini-Screw	MK Meditech	OAT	Class II	2021-12-19
K213051	Nitrile Patient Examination Gloves (Tested for Use with Chemotherapy Drugs)	Yunnan Huazhiyuan Medical Technology Co., Ltd.	LZA	Class I	2021-12-18
K213048	Nitrile Patient Examination Gloves (Tested for Use with Chemotherapy Drugs)	Huayuan Medical Technology(Shangqiu) Co., Ltd.	LZA	Class I	2021-12-18
K212932	Nobel Biocare NobelSpeedy Groovy / Branemark System Mk III TiUnite / Replace Select TC PureSet Tray	Nobel Biocare Services AG	KCT	Class II	2021-12-18
K211624	USA Gloves Nitrile Powder Free Exam Gloves	USA Gloves	LZA	Class I	2021-12-18
K211457	Powder Free Nitrile Examination Gloves (Blue, Black, Indigo)	Ammex Corporation	LZA	Class I	2021-12-18
K213715	Revolution Apex, Revolution Apex Elite, Revolution Apex Plus, Revolution Apex Select,Revolution CT; Revolution CT ES; Revolution CT with Apex edition; Revolution CT ES with Apex edition	GE Healthcare	JAK	Class II	2021-12-17
K213644	Arthrex Knotless Mini TightRopes	Arthrex GmbH	HTN	Class II	2021-12-17
K213627	RF Vapor System	Aqua Medical, Inc.	KNS	Class II	2021-12-17
K213397	InkSpace Imaging Pediatric Body Array	Inkspace Imaging, Inc	MOS	Class II	2021-12-17
K213381	Physica system	Lima Corporate S.p.A.	JWH	Class II	2021-12-17
K212872	Avenger Radial Head System	In2bones USA, LLC	KWI	Class II	2021-12-17
K212340	EMBOGUARD Balloon Guide Catheter	Neuravi Limited	QJP	Class II	2021-12-17
K212059	Surgical Face Mask	Zhongshan Saifute Labor Protective Articles Co., Ltd.	FXX	Class II	2021-12-17
K211531	Cordless Prophy System, Model: i-Polish	Guilin Woodpecker Medical Instrument Co., Ltd	EKX	Class I	2021-12-17
K211209	Hycare Med+ Nitrile Examination Gloves; Hycare Touch Latex Examination Gloves	Hycare International Co., Ltd.	LZA	Class I	2021-12-17
K211172	Single Use Electrosurgical Knife with Fluid Pump System	Micro-Tech (Nanjing) Co., Ltd.	GEI	Class II	2021-12-17