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 1070 of 3531

510(k) clearances, page 1070 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K090857	Valor Ankle Fusion Nail System	Wrightmedicaltechnologyinc	HSB	Class II	2009-07-14
K090655	Portable X-Ray System, Model Powermax 1260	Source-Ray, Inc.	IZL	Class II	2009-07-14
K090527	Sinus Quick It System	Neobiotech Co., Ltd.	DZE	Class II	2009-07-14
K090389	Ap-1000 Blood Glucose Monitoring System	Bestgen Biotech Corp.	NBW	Class II	2009-07-14
K083704	Nutrac Pelvator, Model Pel 200	Verity Scientific, Ltd.	KPI	Class II	2009-07-14
K091479	Aptus Foot System	Medartis AG	HRS	Class II	2009-07-13
K091153	Synchron Systems Enzymatic CO2 (Co2e) Reagent, Model A60291	Siemens Healthcare Diagnostics Inc.	KHS	Class II	2009-07-13
K090188	U-Right Td-4227 No Coding Blood Glucose Monitoring System, Model Td-4222	Taidoc Technology Corporation	NBW	Class II	2009-07-13
K091908	M3 Monitor	Spectrum Medical Inc	DRY	Class II	2009-07-10
K091689	Synapse System 4.0Mm, Oc Fusion System 4.0Mm	Synthes (USA) Products LLC	KWP	Class II	2009-07-10
K091159	Synthes Oracle Plate	Synthes GmbH	KWQ	Class II	2009-07-10
K090988	Gmk Total Knee System	Medacta International SA	JWH	Class II	2009-07-10
K090688	Cook Urological Graft	Cook Biotech, Inc.	PAG	Class II	2009-07-10
K083712	Water Purification Components for Hemodialysis	Dipure, LLC	FIP	Class II	2009-07-10
K083154	Newdeal Hallu Lock Plate System	Newdeal SAS	HRS	Class II	2009-07-10
K091941	Dc-3/Dc-3T Diagnostic Ultrasound System	Shenzhen Mindray Bio-Medical Electronics Co.,LTD	ITX	Class II	2009-07-09
K091909	Litho Laser System	Quanta System Inc.	GEX	Class II	2009-07-09
K091793	Amplatzer Torqvue 3 Delivery Sheath, Model 9-Tv3-08F104, 9-Tv3-08F54	Abbott Medical	DQY	Class II	2009-07-09
K091700	Aircast Venaflow Elite System	DJO, LLC	JOW	Class II	2009-07-09
K091523	Powder-Free Vinyl Patient Examination Gloves	Shijiazhuang Century Plastic Co., Ltd.	LYZ	Class I	2009-07-09
K091515	Spy Scope Intra-Operative Operating System	Novadaq Technologies ULC	GCJ	Class II	2009-07-09
K091474	Easy.touch Insulin Syringe	Masters Healthcare, LLC	FMF	Class II	2009-07-09
K091470	Ranasys Ez Negative Pressure Wound Therapy System, Model 66800059	Smith & Nephew, Inc.	OMP	Class II	2009-07-09
K091308	Alaris Pc Unit, Models 8000 and 8015	Cardinal Health 303,Inc.	FRN	Class II	2009-07-09
K091224	Oxyalert Nirsensors, Accessories for Invos 5100C System, Models: Is-C and Is-S	Somanetics Corp.	MUD	Class II	2009-07-09
K091219	Del Mar Monoaxial Pedicle Screw System	Allez Spine, LLC	NKB	Class II	2009-07-09
K091109	Xpert C. Difficile	Cepheid	LLH	Class I	2009-07-09
K091057	Masimo Rainbow Set Pronto Pulse Co-Oximeter and Accessories	Masimo Corporation	DQA	Class II	2009-07-09
K091044	Spinal USA Anterior Lumbar Plate System	Spinal USA	KWQ	Class II	2009-07-09
K090165	Rainbow Resposable Pulse Co-Oximeter Sensors, Models R2c-25, R2-25, R2c-20 and R2-20	Masimo Corporation	DQA	Class II	2009-07-09
K083812	Refresh Optive Lens Comfort Rewetting Drops	Allergan	LPN	Class II	2009-07-09
K083130	Neobase Non-Derivatized Msms Kit, Model 3040	Revvity Health Sciences, Inc.	NQL	Class II	2009-07-09
K082871	Xact Lens Inserter System, Models 6Mm, 7Mm	Sis Ltd., Surgical Instrument Systems	MSS	Class I	2009-07-09
K081998	H-Wave Sport	Electronic Waveform Laboratory, Inc.	NGX	Class II	2009-07-09
K091882	Azur Peripheral Hydrocoil Endovascular Embolization System	Terumo Cardiovascular Systems Corporation	KRD	Class II	2009-07-08
K091792	Rest Assured Generation II Dental Protector	Ranir, LLC	OBR	Unclassified	2009-07-08
K091681	Finess Sinus Treatment System (Access Sheath Component)	Entellus Medical, Inc.	LRC	Class I	2009-07-08
K091431	Powder-Free, Yellow Vinyl Patient Examination Gloves	Zibo Yusheng Plastic Products Co., Ltd.	LYZ	Class I	2009-07-08
K091397	Ecscope 200	Dyansys, Inc.	DPS	Class II	2009-07-08
K091189	Zodiac Polyaxial Spinal Fixation System	Alphatec Spine, Inc.	MNI	Class II	2009-07-08
K082620	Once-a-Day Vertos Test Pack	Propper Mfg Co Inc	JOJ	Class II	2009-07-08
K091783	Third Eye Retroscope Auxiliary Endoscope System	Avantis Medical Systems, Inc.	FDF	Class II	2009-07-07
K091694	Modification To:latarjet Cortical Screw Set, Models 523Jt, 523J (36-48Mm)	T.A.G. Medical Products Corporation Ltd	HWC	Class II	2009-07-07
K091687	Pacsmate, Model Mmd-4300C/mmd-4300Cx	Iei Technology Corp.	LLZ	Class II	2009-07-07
K090802	Tigrt Mlc, Tigrt Dmlc	Linatech, LLC	IYE	Class II	2009-07-07
K090779	Zodiac Polyaxial Spinal Fixation System	Alphatec Spine, Inc.	MNI	Class II	2009-07-07
K090709	Cortex Dental Implant System	Cortex Dental Implants Industries Ltd.	DZE	Class II	2009-07-07
K090670	Midmark M3 Ultrafast Automatic Sterilizer	Midmark Corp	FLE	Class II	2009-07-07
K090579	Smartscreener-Plus2	Intelligent Hearing Systems Corp.	GWJ	Class II	2009-07-07
K090479	Tanita Body Composition Analyzer, Model Sc-331	Tanita Corporation of America	MNW	Class II	2009-07-07