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 2026-11-02, 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 985 of 3531

510(k) clearances, page 985 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K102380	Evolution Mp Total Knee System	Wrightmedicaltechnologyinc	JWH	Class II	2011-01-07
K102322	Stingray Cervical Cage; Shark Implant (Plif); Bull Shark Implant(plif); Tiger Implant (Tlif); Great White Implants(alif)	Omni Surgical, L.P.	MAX	Class II	2011-01-07
K102304	Breeze C Model C (3W), Breeze C (4W)	Afikim Electric Vehicles	INI	Class II	2011-01-07
K102298	Transtend Br Anchor W/ Orthocord, Transtend Ti Anchor W/orthocord, Transtend Peek Anchor W/orthocord, Healix Transtend	DePuy Mitek, Inc.	HWC	Class II	2011-01-07
K102184	Medpor Contain Can Implant	Porex Surgical, Inc.	NPK	Class II	2011-01-07
K101953	Smdia-1000	Southmedic Inc.	CAF	Class II	2011-01-07
K101823	Arthrex Swivelock Anchors	Arthrex GmbH	MAI	Class II	2011-01-07
K101750	Rpc E-Z Chek 6.8-8.5 Ph Test Strips, Model K100-0117 and E-Z Chek 0-14 Ph Test Strips, Model K100-0104	Reprocessing Products Corp	MNV	Class II	2011-01-07
K101588	Eclipse Vertebral Spacer System-Cervical	Apollo Spine, Inc.	OVE	Class II	2011-01-07
K101371	On Call Plus Diabetes Monitoring Software	Acon Laboratories, Inc.	NBW	Class II	2011-01-07
K093280	Opti Cca-Ts, B-Lac Cassette Model Bp7561	Opti Medical Systems Inc	CHL	Class II	2011-01-07
K103610	Clearview Exact II Influenza a & B Test	Alere Scarborough, Inc D/B/A Binax, Inc.	PSZ	Class II	2011-01-06
K103168	B-Care5 (B-Care5 Sensor Module, Venous Sensor, Holder for Measuring Head)	LivaNova Deutschland GmbH	DRY	Class II	2011-01-06
K103160	Nupro Model 13016901	Cao Group, Inc.	LBH	Class II	2011-01-06
K102683	The Addition	Ob The-Addition, LLC	MUI	Class II	2011-01-06
K102649	Neopop Infant Resuscitator with Flow Meter	Neoforce Group, Inc.	BTM	Class II	2011-01-06
K102520	Bd Nexiva Closed IV Catheter System	Becton Dickinson Infusion Therapy Systems Inc.	FOZ	Class II	2011-01-06
K101616	The Grapplr and Grapplr Extender	T.A.G. Medical Products Corporation Ltd	MBI	Class II	2011-01-06
K101024	Kenz Cardy302 Max	Suzuken Co., Ltd.	MWJ	Class II	2011-01-06
K100577	Acclarent Cyclops Multi-Angle Endoscope	Acclarent Inc	EOB	Class II	2011-01-06
K100358	Central Monitoring System	Edan Instruments, Inc.	HGM	Class II	2011-01-06
K103722	The Sonoace R5 Diagnostic Ultrasound System	Medison Co., Ltd.	ITX	Class II	2011-01-05
K103618	Turbohawk Peropheral Plaque Excision System	Medtronic, Inc.	MCW	Class II	2011-01-05
K103534	Gliderxtreme Pta Balloon Catheter (Cb) (Over the Wire) 0.014 / 0.018 Guide Wire	Trireme Medical, Inc.	DQY	Class II	2011-01-05
K103475	Spineanalyer Model Sapoc	Optasia Medical	LLZ	Class II	2011-01-05
K103287	Synthes 6.0 Cocr and Cpt Ti-3 Rods	Synthes GmbH	NKB	Class II	2011-01-05
K103228	Paramount R Ibf Device	Theken Companies LLC	MAX	Class II	2011-01-05
K103060	Arthrex Tibial Graftbolt	Arthrex GmbH	MBI	Class II	2011-01-05
K103047	Ceretene Soluble Implant Material	Ceremed, Inc.	KHJ	Class II	2011-01-05
K102982	Endobutton Direct	Smith & Nephew, Inc.	MAI	Class II	2011-01-05
K102806	Natrelle 133 Tissue Expander with Suture Tabs	Allergan Medical	LCJ	Unclassified	2011-01-05
K102703	Build-It Total Core	Pentron Clinical	EBF	Class II	2011-01-05
K102698	Pelleve Glidesafe Non-Ablative Wrinkle Treatment System Model Pelleve Glidesafe	Ellman Intl., Inc.	GEI	Class II	2011-01-05
K102544	Smith & Nephew Hip Arthroscopy Repair Instrument Tray	Smith & Nephew, Inc.	KCT	Class II	2011-01-05
K102513	S9 Vpap St with H5i	ResMed Corp	BZD	Class II	2011-01-05
K102379	Ltf-Y0009; Maj-Yoo41; Xoev-3D1	Olympus Medical Systems Corp.	GCJ	Class II	2011-01-05
K102293	Caliber Spacer	Globus Medical, Inc.	MAX	Class II	2011-01-05
K101693	Gaunying Infrared Lamp Model Il50	Foshan Gaunying Electronics Co., Ltd	ILY	Class II	2011-01-05
K101472	Multifit Total Hip System	Otis Biotech Co., Ltd.	LZO	Class II	2011-01-05
K100613	Biomed Wound Cleanser	Biomed Laboratories LLC	FRO	Unclassified	2011-01-05
K103550	Yoboshi Dental Unit	Fosham Yoboshi Medical Equipment Co., Ltd.	EIA	Class I	2011-01-04
K102998	Congruent Bone Plate System	Acumed LLC	HRS	Class II	2011-01-04
K102974	Intellisphere Event Managment System Rel. 10.00	Philips North America LLC	MSX	Class II	2011-01-04
K102226	Dual Incu I	Atom Medical Corporation	FMZ	Class II	2011-01-04
K101350	Radscan Equipment Slicker	Radscan Medical Equipment, Inc.	KKX	Class II	2011-01-04
K093595	Ceraroot Implant System	Oral Iceberg S.L.	DZE	Class II	2011-01-04
K103597	Dx-D 100	AGFA Healthcare Corp.	IZL	Class II	2011-01-03
K103433	F20	Teknimed SAS	NDN	Class II	2011-01-03
K103415	Tanda Max	Pharos Life Corporation	ONE	Class II	2011-01-03
K103319	I-Seed	Theragenics Corp.	KXK	Class II	2011-01-03