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 1012 of 3531

510(k) clearances, page 1012 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K101804	Giraffe and Panda Warmers	GE Healthcare	FMT	Class II	2010-07-21
K101788	Giraffe Omnibed	GE Healthcare	FMZ	Class II	2010-07-21
K101778	Giraffe Incubator	GE Healthcare	FMZ	Class II	2010-07-21
K101674	Wvsm (Wireless Vital Signs Monitor), Model 5.0	Athena GTX	MWI	Class II	2010-07-21
K101596	Kimberly-Clark Purple Nitrile Powder-Free Exam Glove (Chemotherapy Glove) and Kimberly-Clark Purple Nitrile Xtra Powder-	Kimberly-Clark Corporation	LZC	Class I	2010-07-21
K101282	Scoutpro Hemostatic Valve	BIOTRONIK AG	DQY	Class II	2010-07-21
K101255	Alphatec Spine Anterior Lumbar Plating System	Alphatec Spine, Inc.	KWQ	Class II	2010-07-21
K101232	Joinsoon Electronics Mfg Co. Ltd High Speed Digital Thermometer, Model Tc-001	Joinsoon Electronics Mfg Co, Ltd.	FLL	Class II	2010-07-21
K101043	Ect Digital Thermometer	Changshan Estar Electronics Co., Ltd.	FLL	Class II	2010-07-21
K100766	Iba Proton Therapy System, Model Proteus 235	Ion Beam Applications S.A.	LHN	Class II	2010-07-21
K100678	Supra Scan Delivery System	Quantel Medical	GEX	Class II	2010-07-21
K100531	Viscope, Model 100P,100s	Hd Medical Services (India) Pvt.Ltd	DQD	Class II	2010-07-21
K092830	Digital X-Ray Imaging System, Model Drc-1000	Vatech Co., Ltd.	KPR	Class II	2010-07-21
K090661	Nes Reprocessed Varicose Vein RF Catheter	Northeast Scientific Inc.	NUJ	Class II	2010-07-21
K082573	Sargon Non-Expandable Dental Implant	Sargon Ent., Inc.	DZE	Class II	2010-07-21
K100986	Callos Bone Void Filler, Skaffold Next Generation Bone Void Filler, Osteo Vation	Skeletal Kinetics, LLC	MQV	Class II	2010-07-20
K100805	Gallery Laminoplasty Fixation System	Biomet Spine (Aka Ebi, LLC)	NQW	Class II	2010-07-20
K100802	Aesculap Implant Systems Sibd Spinal System	Aesculap Inc	OVD	Class II	2010-07-20
K100702	Startrol LED Lighting Systems (X=# of Pods, Y=# of Leds, N=to Mounting Style) Model X X Y -N-S-W. X=number of Light Pods	Huot Instruments, LLC	FSY	Class II	2010-07-20
K092329	Sopix 2	Sopro	MUH	Class II	2010-07-20
K101625	Cohen Crossover Catheter	Vascular Solutions LLC	DQO	Class II	2010-07-19
K101455	Eko 7 Diagnostic Ultrasound System	Medison Co., Ltd.	IYN	Class II	2010-07-19
K101095	Direct Peroral Cholangioscopy Balloon	Wilson-Cook Medical Inc.	FGE	Class II	2010-07-19
K100765	Fixpine II System	Dio Medical Co., Ltd.	MNI	Class II	2010-07-19
K100031	Ind One Step Fecal Occult Blood Test Model 440-10	Ind Diagnostic, Inc.	KHE	Class II	2010-07-19
K101841	Powdered Vinyl Patient Examination Gloves, Clear (Non-Colored)	Shijiazhuang Sail Plastic Co., Ltd.	LYZ	Class I	2010-07-16
K101840	Powder Free Vinyl Patient Examination Gloves, Clear (Non-Colored)	Shijiazhuang Sail Plastic Co., Ltd.	LYZ	Class I	2010-07-16
K101829	The Sonoace R3 Diagnostic Ultrasound System	Medison Co., Ltd.	ITX	Class II	2010-07-16
K101720	Juliet Ol	Spineart SA	MAX	Class II	2010-07-16
K101343	Powdered Vinyl Patient Examination Gloves	Shijiazhuang Star Plastic Co., Ltd.	LYZ	Class I	2010-07-16
K101146	Water Bottle Cap System	United States Endoscopy Group, Inc.	FEQ	Class II	2010-07-16
K101117	Lev-or Dilation Catheter Otw	Baylis Medical Co., Inc.	DQY	Class II	2010-07-16
K101108	Erbe Esu Model Vio 100 C with Accessories	Erbe USA Inc	GEI	Class II	2010-07-16
K101103	Powdered, Natural Color, Latex Surgical Glove, Sterile Model: Msp1	Best Putra Gloves Sdn Bhd	KGO	Class I	2010-07-16
K101102	Powder-Free, Natural Color, Latex Surgical Glove, Sterile	Best Putra Gloves Sdn Bhd	KGO	Class I	2010-07-16
K101092	Arctic Sun Temperature Management System, Model 5000	Medivance Inc.	DWJ	Class II	2010-07-16
K101087	Reprocessed Restep Compression Sleeves	Ascent Heatlhcare Solutions	JOW	Class II	2010-07-16
K100964	Powdered Vinyl Patient Examination Gloves, Clear (Non-Colored)	Hebei Shenzichen Plastic & Rubber Products Co., LT	LYZ	Class I	2010-07-16
K100752	Peak Universal Bond (Light Cure Resin Adhesive and Chlorhexidine)	Ultradent Products Inc.	KLE	Class II	2010-07-16
K100611	Rs Care Latex Medical Examination Glove (Powder Free)	Riverstone Resources Sdn Bhd	LYY	Class I	2010-07-16
K100603	Rs Safe Blue Nitrile Medical Examination Gloves (Powder Free)	Riverstone Resources Sdn Bhd	LZA	Class I	2010-07-16
K100439	Mediworks Slit Lamp	Shanghai Mediworks Precision Instruments Co., Ltd.	HJO	Class II	2010-07-16
K093784	Athena Multi-Lyte Torch Igg Plus Test System	Zeus Scientific LLC	OPM	Class II	2010-07-16
K092860	Lasemar 800, 1000, 1500	Eufoton S.r.l.	GEX	Class II	2010-07-16
K092813	Astrasonic Spirometer, Model 29-8000	Sdi Diagnostics, Inc.	BZG	Class II	2010-07-16
K092713	Spectre Wireless Encrypted Footswitch and Hand Switch System	Transamerican Medical Imaging	IZL	Class II	2010-07-16
K101851	Ventralight St Mesh	Davol Inc., Sub. C.R. Bard, Inc.	FTL	Class II	2010-07-15
K101796	Pacsmate Mmd-5201M Monitor	Iei Technology Corp.	LLZ	Class II	2010-07-15
K101284	Facet Screw System	NuVasive Inc	MRW	Unclassified	2010-07-15
K101254	Newfix Screw, Wire and Pin Fixarion System	Tecnologia Y Diseno Industrial, S.A de C.V	HWC	Class II	2010-07-15