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 2026-10-22, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 649 of 3529

510(k) clearances, page 649 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K152918	Gun Oil, Pink, Gun Oil H2O, Pink Water	Empowered Products	NUC	Class II	2016-06-02
K152856	Helios III	Laseroptek	GEX	Class II	2016-06-02
K152576	Anker II Dental Implant System	Alliance Global Technology Co., Ltd.	DZE	Class II	2016-06-02
K152519	MTR550 (Tentative) Antimicrobial Silver Wound Gel	Medical Technology Research, Inc.	FRO	Unclassified	2016-06-02
K151229	Abc D-Flex Probe	ConMed Corporation	GEI	Class II	2016-06-02
K160870	Hospira Administration Sets	Abbott Medical	FPA	Class II	2016-06-01
K160573	FirstSense Breast Exam	First Sense Medical, LLC	LHQ	Class I	2016-06-01
K160552	EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System, EV1000 Clinical Platform	Edwards Lifesciences LLC	DXN	Class II	2016-06-01
K160485	VERIFY VH2O2 Indicator Tape	STERIS Corporation	JOJ	Class II	2016-06-01
K160264	Additive Orthopaedics Hammertoe Correction System	Additive Orthopaedics, LLC	HTY	Class II	2016-06-01
K153552	AGE Automatic Upper Arm Blood Pressure Monitor	Ageless Health Industrial Co., Ltd.	DXN	Class II	2016-06-01
K153288	Voyant Open Fusion Device	Applied Medical Resources Corp	GEI	Class II	2016-06-01
K153165	NEPHROCHECK Test Kit, ASTUTE140 Meter, NEPHROCHECK Liquid Controls Kit, NEPHROCHECK Calibration Verification (Cal Vers) Kit	Astute Medical, Inc.	PIG	Class II	2016-06-01
K153056	Hermes Medical Imaging Suite v5.6	Hermes Medical Solutions AB	KPS	Class II	2016-06-01
K152635	QUANTA Flash Scl-70, QUANTA Flash Scl-70 Calibrators, QUANTA Flash Scl-70 Controls	Inova Diagnostics, Inc.	LLL	Class II	2016-06-01
K152458	Gemini Bonded Sterilization Wrap	MEDLINE INDUSTRIES, LP - Northfield	FRG	Class II	2016-06-01
K151987	DCI Edge Dental Chair with Operative Unit	Dci	KLC	Class I	2016-06-01
K161300	Acclarix AX8 Diagnostic Ultrasound System	Edan Instruments, Inc.	IYO	Class II	2016-05-31
K161246	Ez3D-i / E3	Ewoosoft Co., Ltd	LLZ	Class II	2016-05-31
K161209	Cirona 6400	Devon Medical Products	JOW	Class II	2016-05-31
K160900	CapSure Fixation System - Straight 5mm x 37 cm – 30 Permanent fasteners, CapSure Fixation System - Straight 5mm x 37 cm – 15 Permanent fasteners	C.R. Bard Inc	GDW	Class II	2016-05-31
K160647	IMMULITE 2000 Third Generation TSH, IMMULITE 2000 Free T4	Siemens Healthcare Diagnostics Inc.	JLW	Class II	2016-05-31
K160623	FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical Suture	M/s. Meril Endo Surgery Private Limited.	GAP	Class II	2016-05-31
K152583	KARL STORZ Endoscopic ICG Imaging System	Karl Storz Endoscopy-America, Inc.	OWN	Class II	2016-05-31
K152340	NAR Sharps Shuttle; NAR Sharps Shuttle Pack of six	North American Rescue LLC.	MMK	Class II	2016-05-31
K150979	CT/MR Compatible M.A.C. Interstitial GYN Template	Mick Radio-Nuclear Instruments, Inc.	JAQ	Class II	2016-05-31
K161170	BD Eclipse Hypodermic Needle	Becton Dickinson & Co	FMI	Class II	2016-05-27
K160305	neoBLUE® LED Phototherapy System	Natus Medical Incorporated	LBI	Class II	2016-05-27
K153736	3mensio Workstation	PIE Medical Imaging B.V.	LLZ	Class II	2016-05-27
K153149	Digital Thermometer, Models MT-1027, MT-4127, MT-1032, MT-4132, MT-4333, MT-4326, MT-4726, MT-4335, MT-4735, MT-09, MT-30, MT-31, MT-36	Sejoy Electronics & Instruments Co., Ltd.	FLL	Class II	2016-05-27
K152826	NoCord	Centrix, Inc.	ELW	Class II	2016-05-27
K152776	Glocyte Automated Cell Counter System	Advanced Instruments, LLC	GKL	Class II	2016-05-27
K152167	BIJOU Orthodontic Ceramic Bracket	World Bio Tech Co Ltd	NJM	Class II	2016-05-27
K151781	Cardiac Trigger Monitor, Cardiac & Regulatory Synchronization Monitor	Ivy Biomedical Systems, Inc.	DRT	Class II	2016-05-27
K150044	O-Pep	Pari Respiratory Equipment, Inc.	BWF	Class II	2016-05-27
K161228	Radiance Ultra Series ZeroWire Embedded	NDS Surgical Imaging, LLC	GCJ	Class II	2016-05-26
K161221	Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula Plug	Cook Biotech Incorporated	FTM	Class II	2016-05-26
K161190	G7 Dual Mobility System, Active Articulation System	Zimmer GmbH	LPH	Class II	2016-05-26
K161167	Seal Single-Use Biopsy Valve	Boston Scientific Corporation	OCX	Class II	2016-05-26
K160980	Threshold Pedicular Fixation System, Palisade Pedicular Fixation System	Spineology, Inc.	NKB	Class II	2016-05-26
K160902	Mariner Pedicle Screw System	SeaSpine Orthopedics Corporation	NKB	Class II	2016-05-26
K160809	Reveal LINQ	Medtronic, Inc.	MXD	Class II	2016-05-26
K160713	Stealth-Midas System	Medtronic Powered Surgical Solutions	OLO	Class II	2016-05-26
K160501	Noxilizer Surgical Ruler	Noxilizer, Inc.	FTY	Class I	2016-05-26
K160393	AdTec	Aesculap Inc	GCJ	Class II	2016-05-26
K160344	Si-Hy (olifilcon B) sperical silicone hydrogel soft contact lens, Si-Hy (olifilcon B) multifocal silicone hydrogel soft contact lenses, Si-Hy (olifilcon B) toric silicone hydrogel soft contact lens2/16/2016	Visco Vision Inc.	LPL	Class II	2016-05-26
K153379	AxSOS 3Ti	Stryker Corp.	HRS	Class II	2016-05-26
K152818	Yongchang Powder-Free Yellow Vinyl Patient Examination Gloves	Ideal Plastic Co., Ltd.	LYZ	Class I	2016-05-26
K152612	eSensor Warfarin Sensitivity Saliva Test	Genmark Diagnostics, Incorporated	ODW	Class II	2016-05-26
K152571	Stivax	Biegler GmbH	BWK	Unclassified	2016-05-26