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 2026-10-12, 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 284 of 3528

510(k) clearances, page 284 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K220761	CIRCUL8 Connect DVT Prevention Device	Precision Medical Products	JOW	Class II	2022-06-03
K220672	Blue Powder Free Nitrile Examination Glove with Grape Scented, Chemotherapy Drugs and Fentanyl Test Claim	Riverstone Resources Sdn Bhd	LZA	Class I	2022-06-03
K220665	Surgical Gown, Blue, Sterile; Surgical Gown, Blue, Non-Sterile	Excellent Medical Technology Group Co., Ltd.	FYA	Class II	2022-06-03
K220652	Knee 3	Brainlab, Inc.	OLO	Class II	2022-06-03
K220633	MICROLET NEXT lancing device, MICROLET Lancet	Medrad, Inc.	QRL	Class II	2022-06-03
K220321	Aptima Combo 2 Assay (250 test kit) Panther, Aptima Combo 2 Assay (250 test kit) Tigris, Aptima Trichomonas Vaginalis Assay (250 test kit) Panther, Aptima Trichomonas Vaginalis Assay (250 test kit) Tigris	Hologic, Inc.	QEP	Class II	2022-06-03
K220205	3D Anatomic Models	Ricoh USA, Inc.	LLZ	Class II	2022-06-03
K214089	FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2	FUJIFILM Corporation	ODG	Class II	2022-06-03
K214063	Model 121 Biopsy Needle, Model 111 Biopsy Needle, Model 112 Biopsy Needle, and Model 131 Disposable Coaxial Biopsy Needle	Guangzhou Shengwei Medical Devices Co., Ltd.	KNW	Class II	2022-06-03
K213988	SOFT PLUG Extended Duration 180 Tapered Canalicular Plug	Oasis Medical, Inc.	LZU	Unclassified	2022-06-03
K213977	TrueBeam, TrueBeam STx, Edge, VitalBeam	Varian Medical Systems, Inc.	IYE	Class II	2022-06-03
K213971	Atrial Fibrillation History Feature	Apple Inc.	QDB	Class II	2022-06-03
K213931	VITEK 2 AST-Gram Negative Omadacycline (<=0.25 - >=16 µg/mL)	bioMerieux, Inc.	LON	Class II	2022-06-03
K213924	Gastric Alimetry System	Alimetry Ltd	MYE	Class II	2022-06-03
K213332	Multifrax Laser System	Paradigm Medical, Inc.	ONG	Class II	2022-06-03
K211567	BiMobile Instruments (for BiMobile Dual Mobility System)	Waldemar Link GmbH & Co. KG	LZO	Class II	2022-06-03
K211046	eCareManager 4.5	Visicu, Inc.	MSX	Class II	2022-06-03
K210741	KLS Martin Neuro Rongeurs	KLS-Martin L.P.	HAE	Class II	2022-06-03
K210371	Portable Oxygen Concentrator, model: P2-E6	Qingdao Kingon Medical Science and Technology Co.,Ltd	CAW	Class II	2022-06-03
K210084	Silkro	Hironic Co., Ltd.	GEI	Class II	2022-06-03
K220930	Restoris Multi-Compartmental Knee System	Mako Surgical Corp.	HSX	Class II	2022-06-02
K220927	IPL Hair Removal	Shenzhen Qiaochengli Technology Co., Ltd	OHT	Class II	2022-06-02
K220861	M6-C Artificial Cervical Disc Instruments AS	Spinal Kinetics, LLC	QLQ	Class II	2022-06-02
K220751	Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMA	Straumann USA, LLC	NHA	Class II	2022-06-02
K220632	Boss Crossing Support Catheter	Marvao Medical Devices Ltd.	DQY	Class II	2022-06-02
K220581	Zavation eZspand Interbody System	Zavation Medical Products, LLC	MAX	Class II	2022-06-02
K220547	PureZero MARIN Nitrile Powder-Free Exam Gloves, PureZero MARIN-XTRA Nitrile Powder-Free Exam Gloves	O&M Halyard, Inc.	LZA	Class I	2022-06-02
K220541	PureZero LIMON Nitrile Powder-Free Exam Gloves, PureZero LIMON-XTRA Nitrile Powder-Free Exam Gloves	O&M Halyard, Inc.	LZA	Class I	2022-06-02
K220164	Rayvolve	Azmed SAS	QBS	Class II	2022-06-02
K220008	Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Thermogard HQ Start-Up Kit, Thermogard HQ Start-Up Kit EX, Thermogard HQ Console	ZOLL Circulation, Inc.	NCX	Class II	2022-06-02
K214049	Leaseir MHR Xcell	Leaseir Technologies SLU	GEX	Class II	2022-06-02
K213588	Q2 IV Administration Sets	Quest Medical, Inc	FPA	Class II	2022-06-02
K213261	EpilME	Neauvia North America, Inc	GEX	Class II	2022-06-02
K213239	Endoscopic Injection Needle	Beijing Zksk Technology Co., Ltd.	FBK	Class II	2022-06-02
K212288	Minjie Catheter System	Kai Medtech, LLC	QJP	Class II	2022-06-02
K210758	Q Patch	Medicalgorithmics S.A.	MWJ	Class II	2022-06-02
K200754	Hemosure Accu-Reader A100	WHPM Inc.	OOX	Class II	2022-06-02
K221264	FROG Forceps Valve (VAL1-F1-100)	FUJIFILM medwork GmbH	ODC	Class II	2022-06-01
K221002	IPL Hair Removal Device, Model(s): UI04A, UI04B, UI04C	Shenzhen Ulike Smart Electronics Co.,Ltd	OHT	Class II	2022-06-01
K220973	CoreLink Navigation Instruments	Corelink, LLC	OLO	Class II	2022-06-01
K220650	TriMed Ripcord Device	Trimed Inc	HTN	Class II	2022-06-01
K220488	Disposable Nitrile Powder-Free Examination Gloves (Tested for Use with Chemotherapy Drugs)	Anhui Zhong Lian Latex Gloves Manufacturing Co., Ltd.	LZA	Class I	2022-06-01
K220058	BeneVision Central Monitoring System	Shenzhen Mindray Bio-Medical Electronics Co.,LTD	MSX	Class II	2022-06-01
K213838	AneuGuide	ArteryFlow Technology Co., Ltd.	PZO	Class II	2022-06-01
K213753	Purgo	Aeroclean Technologies, Inc.	FRA	Class II	2022-06-01
K213201	DeltaFil, DeltaFil Conditioner	DMG Chemisch Pharmazeutische Fabrik GmbH	EMA	Class II	2022-06-01
K212445	freeflex+ Transfer Adapter	Fresenius Kabi AB	LHI	Class II	2022-06-01
K210107	Genadyne UNO Plus (UNO+) Negative Pressure Wound Therapy System	Genadyne Biotechnologies, Inc.	OMP	Class II	2022-06-01
K203233	4CIS Chiron Spinal Fixation System	Solco Biomedical Corp.	NKB	Class II	2022-06-01
K221440	Liverty™ TIPS Access Set	Bard Peripheral Vascular Inc	DYB	Class II	2022-05-31