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 650 of 3529

510(k) clearances, page 650 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K152556	Oragene Dx	DNA Genotek Inc.	OYJ	Class II	2016-05-26
K152535	Z5 Slit lamp microscope, Z2 Slit lamp microscope	Takagi Seiko Co., Ltd.	HJO	Class II	2016-05-26
K152464	ORAcollect.Dx	DNA Genotek Inc.	OYJ	Class II	2016-05-26
K152319	Auris Robotic Endoscopy System (ARES)	Auris Surgical Robotics, Inc.	EOQ	Class II	2016-05-26
K151540	MC BIO Supertack Tack 3mm, 4mm and 5mm	Eli-KA Technologies LLC	DZL	Class II	2016-05-26
K160570	Creatine Kinase	Roche Diagnostics Operations (Rdo)	JHS	Class II	2016-05-25
K160449	Penumbra System, Penumbra Pump MAX	Penumbra Inc.	NRY	Class II	2016-05-25
K153762	Smartdop XT6	Koven Technology, Inc.	JOP	Class II	2016-05-25
K153743	Piezosurgery Plus	Mectron S.p.A.	JDX	Class II	2016-05-25
K153629	ArcadiusXP C Spinal System	Aesculap Inc	OVE	Class II	2016-05-25
K153582	Prometheus ChitoGauze XR PRO	Hem Con Medical Technologies, Inc.	QSY	Unclassified	2016-05-25
K153477	EMMa Electronic Monitoring Management	Vitasystems GmbH	DSI	Class II	2016-05-25
K153345	Stryker Orthopaedics Hip Systems Labeling Update	Stryker Orthopaedics	LPH	Class II	2016-05-25
K153026	Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body Pro-Respiratory Belt, Rail Clamp for Respiratory Belt, Pressure Gauge Replacement	Medtec, Inc. D/B/A Civco Medical Solutions	IYE	Class II	2016-05-25
K152789	Flex Scoring Catheter	VENTUREMED GROUP, Inc	PNO	Class II	2016-05-25
K151784	ActTrust	Condor Instruments Ltda. - Epp	LEL	Class II	2016-05-25
K161208	CROSSER CTO Recanalization Catheter	Bard Peripheral Vacular, Inc.	PDU	Class II	2016-05-24
K160533	Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System)	Penumbra Inc.	QEW	Class II	2016-05-24
K160197	Haemonetics Cell Saver Elite Autotransfusion System	Haemonetics Corporation	CAC	Class II	2016-05-24
K153162	Hypocore	Novocor Medical Systems, Inc.	NCX	Class II	2016-05-24
K161176	ARTOURA Breast Tissue Expanders with Smooth Surface	Mentor Worldwide, LLC	LCJ	Unclassified	2016-05-23
K153597	Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card	Healgen Scientific LLC	JXM	Class II	2016-05-23
K153099	Inclusive Tapered Implant System	Prismatik Dentalcraft, Inc.	DZE	Class II	2016-05-23
K152544	Agem Ag Mesh Dressing with Silver	Shenzhen Yuanxing Nano-Pharma Co., Ltd.	FRO	Unclassified	2016-05-23
K150956	PINPOINT Endoscopic Fluorescence Imaging System	Novadaq Technologies ULC	GCJ	Class II	2016-05-23
K161140	VITROS Chemistry Products Calibrator Kit 3	Ortho-Clinical Diagnostics, Inc.	JIX	Class II	2016-05-20
K161123	Baha 5 Power Sound Processor	Cochlear Americas	LXB	Class II	2016-05-20
K160889	BIB Stent Placement Catheter	Numed Inc	NVM	Class II	2016-05-20
K160877	United Urologics Closed System Catheter	Robling Medical, LLC	KOD	Class II	2016-05-20
K160810	ViZion DR + Wireless	Viztek, LLC	MQB	Class II	2016-05-20
K160506	Planmeca ProMax 3D Max, Planmeca Maximity	Planmeca Oy	OAS	Class II	2016-05-20
K160463	Reliance Lumbar IBF System	Reliance Medical Systems, LLC	MAX	Class II	2016-05-20
K160416	CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal Miniprobes	Mauna Kea Technologies	OWN	Class II	2016-05-20
K160289	MasterLoc Stem	Medacta International SA	LZO	Class II	2016-05-20
K160152	Trillium Oval V 5.1 MRI System	FUJIFILM Healthcare Americas Corporation	LNH	Class II	2016-05-20
K160091	Temperature Probe, Affinity Temperature Probe	Medtronic, Inc.	FLL	Class II	2016-05-20
K160065	GEMSS Medical System Surgical Mobile Fluoroscopic X-ray System	Gemss Medical Systems Co., Ltd.	OXO	Class II	2016-05-20
K160052	CUR Model 1	Thimble Bioelectronics, Inc.	NUH	Class II	2016-05-20
K153650	Microdent Ektos Implant System	Implants Microdent System S.L	DZE	Class II	2016-05-20
K153359	BardPort®, SlimPort®, and X-Port® Implanted Ports	C.R. Bard Inc	LJT	Class II	2016-05-20
K153334	Oral-B 5% Sodium Fluoride Varnish	Young Dental Manufacturing Co 1, LLC.	LBH	Class II	2016-05-20
K153127	everX Posterior	GC America Inc.	EBF	Class II	2016-05-20
K152559	TruAbutment DS	TruAbutment Inc.	NHA	Class II	2016-05-20
K152507	Dr. Wolff Vagisan Moisturising Cream	Dr. August Wolff GmbH & Co. KG Arzeimittel	NUC	Class II	2016-05-20
K152423	Sunfire 32 Tanning Bed; Sunfire 24 Tanning Bed; Sunfire 16 Tanning Canopy; Sunfire 12R Tanning Canopy	Sunfire Industries, Inc.	LEJ	Class II	2016-05-20
K152103	IPS Style Ceram, IPS Style Ceram One, IPS Style Press	Ivoclar Vivadent, Inc.	EIH	Class II	2016-05-20
K151492	Kudu	R82 a/S	IOR	Class I	2016-05-20
K161125	OptiCross X, 40 MHz Coronary Imaging Catheter	Boston Scientific Corporation	OBJ	Class II	2016-05-19
K161102	Nanostim Introducer Kit	Abbott Medical	DYB	Class II	2016-05-19
K161041	OsteoMed ExtremiLOCK Wrist Plating System	Osteomed	HRS	Class II	2016-05-19