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 2026-11-05, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,132 of the 176,529 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	2,732

176,529 records, page 1279 of 3531

510(k) clearances, page 1279 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K060097	Grossman Self-Retaining Low Profile Brain Retractor, Model 04-001-00	KLS-Martin L.P.	GZT	Class II	2006-02-27
K060090	Dimension Vista Thyroid Stimulating Hormone Flex Reagent Cartridge	Siemens Healthcare Diagnostics Inc.	JLW	Class II	2006-02-27
K060046	Dermastream	Enzysurge, Ltd.	NAD	Class I	2006-02-27
K060011	Miig Sr	Wrightmedicaltechnologyinc	MQV	Class II	2006-02-27
K053605	Aeroeclipse II Breath Actuated Nebulizer	Trudell Medical Intl.	CAF	Class II	2006-02-27
K053340	Trabecular Metal Tibial and Femoral Cone Augments	Zimmer Trabecular	MBH	Class II	2006-02-27
K053182	Drlock Distal Radius Volar System	TORNIER Inc.	HRS	Class II	2006-02-27
K053088	Slactive Implants	Straumann USA, LLC	DZE	Class II	2006-02-27
K052665	Granton Medical 121-135 C Self-Seal Sterilization Pouches	Granton Medical, Ltd.	FRG	Class II	2006-02-27
K050586	Leone Implant System	Leone S.p.A.	DZE	Class II	2006-02-27
K060395	Cryo, Model V6.0	Zimmer Elektromedizin GmbH	GEX	Class II	2006-02-24
K060350	Construx Pl/tl Peek Partial Vbr System	Blackstone Medical, Inc.	MQP	Class II	2006-02-24
K060335	File-Eze	Ultradent Products Inc.	KJJ	Unclassified	2006-02-24
K060268	Pediatric Urinary Catheter	Clay Kennard	GBM	Class II	2006-02-24
K060049	Reprocessed Compression Sleeves	Alliance Medical Corp.	JOW	Class II	2006-02-24
K053504	Microscan Synergies Plus Gram-Positive Mic/combo Panels with Erythromycin (0.12-16 Ug/ml)	Siemens Healthcare Diagnostics Inc.	LON	Class II	2006-02-24
K053277	Cps Direct Sl Outer Catheter	Abbott Medical	DQY	Class II	2006-02-24
K053223	Triton/tru-Trac/tx/triton Dts Traction	Chattanooga Group, Inc.	ITH	Class II	2006-02-24
K052732	Abracair Air Cleaner, Model Qtz300-60; Abracair Air Cleaner, Model Ti 100-30P	Abracair, Inc.	FRA	Class II	2006-02-24
K052241	Disc-Fx System	Ellman International, Inc.	HRX	Class II	2006-02-24
K051137	Techdevice Occlusion Balloon Catheter	Techdevice Corporation	MJN	Class II	2006-02-24
K051097	Geratherm Sos-Rescue Blanket	Rg Ent., Inc.	DWJ	Class II	2006-02-24
K051020	Es-160	Lhasa Oms, Inc.	GZJ	Class II	2006-02-24
K060334	Gi Dentstat	Ultradent Products Inc.	EMA	Class II	2006-02-23
K060253	Sterling Interference Screw Ht, Sterling Interference Screw St.	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)	HWC	Class II	2006-02-23
K060150	Smartstep System/smarstep Clinic System	Andante Medical Devices, Ltd.	IRN	Class II	2006-02-23
K060017	Mako Surgical Unicondylar Knee System	Mako Surgical Corp.	HSX	Class II	2006-02-23
K053561	Bio-Mini Revo Suture Anchor	Conmed Linvatec	HWC	Class II	2006-02-23
K053412	Flexiscope, Models 50Mh and 50 Mhc	Schoelly Imaging, Inc.	FWF	Class I	2006-02-23
K053378	Loop Recorder Vitaphone, 3100 Series	Tms Telemedizinische Systeme GmbH	DXH	Class II	2006-02-23
K053364	Halux Iris Examination and Surgical Lamp	Waldmann Lighting	FTD	Class II	2006-02-23
K053344	Bioraptor Suture Anchor, Twinfix 2.8 Mm Suture Anchor, Twinfix 3.5 Mm Suture Anchor	Smith & Nephew, Inc.	HWC	Class II	2006-02-23
K052617	Ferritin Lit Assay, Catalog No. 7010; Ferritin Calibrator Set, Catalog No. 7510; Ferritin Controls, Level-L & Level-H,	Good Biotech Corp.	DBF	Class II	2006-02-23
K052448	Pocket Breathalyzer. Connectables	Connectables, LLC	DJZ	Class I	2006-02-23
K050757	Flex-Aid Liquid Gel Bandage and Dermaflex Gel Tissue Adhesive Professional Liquid Bandage	Chemence Medical Inc.	KMF	Class I	2006-02-23
K060283	Transet System	Bonutti Research, Inc.	HTY	Class II	2006-02-22
K060259	Digital Fluoroscopic Imaging Systems - Innova 3131 & Innova 2121	GE Healthcare	OWB	Class II	2006-02-22
K060117	Bovie Button Remote Hand Switch	Apyx Medical Corporation	GEI	Class II	2006-02-22
K060113	Dermacyn Wound Care	Sonoma Pharmaceuticals, Inc.	FRO	Unclassified	2006-02-22
K060004	Caldera Mesh	Caldera Medical, Inc.	FTL	Class II	2006-02-22
K053625	Nasalguard	Trutek Corp	NUP	Class II	2006-02-22
K053604	Wavelight Idas	Wavelight Laser Technologie AG	GEX	Class II	2006-02-22
K053493	Berry Fruity Teether	Evenflo Company, Inc.	KKO	Class II	2006-02-22
K053484	Infinity Gamma / Gammaxl, Infinity Vista	Draeger Medical Systems, Inc.	MHX	Class II	2006-02-22
K053424	Popmesh	Caldera Medical, Inc.	FTL	Class II	2006-02-22
K053260	Ossix -Plus	Colbar Lifescience, Ltd.	NPL	Class II	2006-02-22
K053125	Procera Bridge Zirconia	Nobel Biocare AB	NHA	Class II	2006-02-22
K053068	Procera Bridge Laminate, Model 40-4002	Nobel Biocare AB	NHA	Class II	2006-02-22
K053050	Procera Bridge Alumina	Nobel Biocare AB	NHA	Class II	2006-02-22
K050783	Issys Drug Flow Monitor	Integrated Sensing Systems, Inc.	FLN	Class II	2006-02-22