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 2026-10-29, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 858 of 3530

510(k) clearances, page 858 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K123324	Selectra 7F Catheters	BIOTRONIK AG	DQY	Class II	2013-01-11
K123302	Ib Clinic	Imaging Biometrics, LLC	LLZ	Class II	2013-01-11
K123270	Powerease System	Medtronic Sofamor Danek USA Inc	HBE	Class II	2013-01-11
K123048	Patient Monitor Models Pm-2000A, Pm-2000A+, Pm-2000A Pro	Advanced Instrumentations, Inc.	MHX	Class II	2013-01-11
K122878	Hd-Ivus Ultrasound Imaging System	Silicon Vally Medical Instruments, Inc.	OBJ	Class II	2013-01-11
K122866	Vivix-S with Vxvue	Vieworks Co., Ltd.	MQB	Class II	2013-01-11
K122836	Affirm Breast Biopsy Guidance System	Hologic, Inc.	IZH	Class II	2013-01-11
K122685	Angiosculpt Pta Scoring Balloon Catheter	Spectranetics Corp.	PNO	Class II	2013-01-11
K122576	Transform Occlusion Balloon Catheter (Compliant and Super Compliant	Stryker Corp.	MJN	Class II	2013-01-11
K122572	Icam Fundus Camera	Optovue Inc.	HKI	Class II	2013-01-11
K121765	Sculptor Robotic Guidance Arm (Rga)	Stanmore Implants Worldwide, Ltd.	OLO	Class II	2013-01-11
K121313	Mtf New Bone Void Filler	Musculoskeletal Transplant Foundation d/b/a/ MTF Biologics	MQV	Class II	2013-01-11
K121254	Camber Spine Technologies Tls 5.0 Inerbody Cage	Camber Spine Technologies	MAX	Class II	2013-01-11
K120949	Infrascanner	Infrascan, Inc.	OPT	Class II	2013-01-11
K123911	Senomark Ultra Breast Tissue Marker	C.R. Bard Inc	NEU	Class II	2013-01-10
K123874	Interlink System Buretrol Solution Sets, Interlink System Buretrol Solution Sets, Continued, Clearlink System Buretrol S	Baxter Healthcare Corporation	FPA	Class II	2013-01-10
K123849	New Comfort-Fit Dental Guard	Den Tek Oral Care, Inc.	OBR	Unclassified	2013-01-10
K123845	Me	Syneron Beauty	ONF	Class II	2013-01-10
K123516	Cryo-Touch IV	Myoscience, Inc.	GXH	Class II	2013-01-10
K123438	Xenx Stone Management Device	Xenolith Medical	OCY	Class II	2013-01-10
K123396	I.flex by Tcs	Thermoplastic Comfort Systems, Inc.	EBI	Class II	2013-01-10
K123342	Optetrak Logic Crc Tibial Insert	Exactech, Inc.	JWH	Class II	2013-01-10
K123223	Ec Single Use, Polypectomy Snare	Boston Scientific Corporation	FDI	Class II	2013-01-10
K123201	Aquamantys Endo Dbs 8.7 Dissecting Bipolar Sealer	Medtronic Navigation, Inc	GEI	Class II	2013-01-10
K122922	E-Beam Nd: Yag Laser	Eclipse Aesthetics, LLC	GEX	Class II	2013-01-10
K122771	Spinal Elements Cervical Intervertebral Body Fusion System	Spinal Elements, Inc	OVE	Class II	2013-01-10
K122687	Blood Culture Holder	Greiner Bio-One North America, Inc.	JKA	Class II	2013-01-10
K122391	Medtronic Xomed, Inc.	Medtronic Xomed, Inc.	LRK	Class II	2013-01-10
K122383	Em3 Aem Monitor Aem Connectors	Encision, Inc.	GEI	Class II	2013-01-10
K122077	Manometer	Intersurgical Ltd.	CAP	Class II	2013-01-10
K121959	Evis Exera III Video System	Olympus Medical Systems Corp.	EOQ	Class II	2013-01-10
K121206	Detect	Forum Engineering Technologies, Ltd.	LQY	Unclassified	2013-01-10
K123863	Ucp Compact Drug Test Cards, Ucp Compact Drug Test Cups	Ucp Biosciences, Inc.	DKZ	Class II	2013-01-09
K123798	Liquidchek Diabetes Control; Level 1, Level 2, Level 3, Trilevel Minipak	Bio-Rad Laboratories Inc.	JJX	Class I	2013-01-09
K123781	Transtek Glass Body Fat Analyzer	Zhongshan Transtek Electronics Co., Ltd	MNW	Class II	2013-01-09
K123441	Stryker Crossflow Arthroscopy Pump	Stryker Corp.	HRX	Class II	2013-01-09
K123213	Bd Phaseal Closed System Transfer Device	Becton Dickinson & Co	ONB	Class II	2013-01-09
K122914	Affinity Fusion Cardiotomy/venous Reservior with Balance Biosurface Model Bb841, Affinity Fusion Cardiotomy/ Venous Rese	Medtronic, Inc.	DTN	Class II	2013-01-09
K122704	Best Localization Needle with I-125 Seed	Best Medical Intl.	KXK	Class II	2013-01-09
K122357	Merits Model P322fwd Powered Wheelchair	Merits Health Products, Inc.	ITI	Class II	2013-01-09
K122336	Q-Fix Suture Anchor, 1.8Mm Q-Fix Access Tools (Drill Guide W/obturator, Drill Bit) 1.8Mm	Eleven Blade Solutions, Inc.	MBI	Class II	2013-01-09
K122062	Aptima Trichomonas Vaginalis Assay - Panther	Hologic, Inc.	OUY	Class II	2013-01-09
K121399	Luminex Flexmap 3D Instrument System, Luminex Xponent 4.0 Spi Software, Flexmap 3D IVD Calibration Kit, Flexmap 3D IVD P	Luminex Corporation	NSU	Class II	2013-01-09
K123868	Interlink System Lever Lock Cannula with Check Valve, Secondary Medication Sets, Solution Sets, Continu-Flo Solution Set	Baxter Healthcare Corporation	FPA	Class II	2013-01-08
K123847	Malleable Tip Endoscopic Applicator	Micromedics, Inc.	GCJ	Class II	2013-01-08
K123476	Mega 5.5 Spine System	Lsk Biopartners, Inc.	MNH	Class II	2013-01-08
K123371	Alignrt Plus	Vision Rt Inc	IYE	Class II	2013-01-08
K123180	Falcon Spacer	Synthes (USA) Products LLC	MAX	Class II	2013-01-08
K122698	Aequalis Ascend Flex Shoulder System	Tornier S.A.S.	KWS	Class II	2013-01-08
K122048	Collagen Tendon Sheet-D	Rotation Medical, Inc.	FTM	Class II	2013-01-08