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 609 of 3529

510(k) clearances, page 609 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K162536	GingiKnit+, GingiBraid+, GingiBraid+ Shortcut, and UniBraid+ impregnated Aluminum Potassium Sulfate Retraction Cord	Sybron Dental Specialties, Inc.	MVL	Unclassified	2017-02-03
K162439	AxSOS 3 Ti; Stryker Plating System	Stryker Corp.	HRS	Class II	2017-02-03
K162388	CuraSeal Percutaneous Intraluminal Closure System for Anorectal Fistulas(PICS-AF)	Curaseal, Inc.	FTM	Class II	2017-02-03
K162106	Micro-current Wrinkle Reduction Facial service, model EP-400	Li-Tek Electronic Technology Corporation	NFO	Class II	2017-02-03
K161901	TrapLiner catheter	Vascular Solutions LLC	DQY	Class II	2017-02-03
K161258	NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin Kit	Inova Diagnostics, Inc.	MOB	Class II	2017-02-03
K161056	Telemetry Transmitter	Edan Instruments, Inc.	MHX	Class II	2017-02-03
K161025	priti multidisc ZrO2 High Translucent	Pritidenta GmbH	EIH	Class II	2017-02-03
K152432	ActiPatch(R)	Bioelectronics Corporation	PQY	Class II	2017-02-03
DEN150035	SEEKER System	Baebies Inc.	PQW	Class II	2017-02-03
K170061	ProMIS™ Fixation System	Premia Spine Ltd.	NKB	Class II	2017-02-02
K170019	Aquilion Lightning, TSX-036A/1, V8.4	Toshibamedical Systems Corporation	JAK	Class II	2017-02-02
K163511	NovaGuard SA Pro Safety System	West Pharmaceutical Services, Inc.	MEG	Class II	2017-02-02
K163428	HA Minuteman G3-R MIS Fusion Plate	Spinal Simplicity, LLC	PEK	Class II	2017-02-02
K163268	FlexCath Select Steerable Shealth and Dilator	Medtronic CryoCath LP	DYB	Class II	2017-02-02
K163123	Q-Switched Nd:YAG Laser Therapy Systems	Beijing Sincoheren Science & Technology Development Co., Ltd	GEX	Class II	2017-02-02
K161552	0.9% Sodium Chloride Injection, USP BD PosiFlush SP Syringe	Becton Dickinson & Co	NGT	Class II	2017-02-02
K161103	US SA Implant System	OSSTEM Implant Co., Ltd.	DZE	Class II	2017-02-02
K160835	Titan 3W	Tzora Active Systems, Ltd.	INI	Class II	2017-02-02
K163440	Stealth Staple System	First Ray, LLC	JDR	Class II	2017-02-01
K163095	Lyme B. burgdorferi (IgG) MarStripe Test	Trinity Biotech, PLC	LSR	Class II	2017-02-01
K163083	VITEK 2 AST-GN Tobramycin (</=1->/= 16 ug/mL); VITEK 2 AST-Gram Negative Tobramycin (</=1->/=16 ug/mL)	bioMerieux, Inc.	LON	Class II	2017-02-01
K162958	MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface; MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface with Bridge; MYOtherm XP Cardioplegia Delivery System; MYOtherm XP Cardioplegia Delivery System with Bridge	Medtronic, Inc.	DTR	Class II	2017-02-01
K162726	Exactech® Equinoxe® Preserve Stem	Exactech, Inc.	PHX	Class II	2017-02-01
K162624	Pre-Formed Penile Silicone Block	International Medical Devices, Inc	MIB	Class II	2017-02-01
K162467	Twin-Pass Torque	Vascular Solutions LLC	DQY	Class II	2017-02-01
K162454	PicoWay Laser System	Syneron Candela Corporation	GEX	Class II	2017-02-01
K162144	iHealth Wireless Blood Pressure Monitor	Andon Health Co., Ltd	DXN	Class II	2017-02-01
K161587	Memodyn Staple	Austin & Associates, Inc./Telos Medical Equipment	JDR	Class II	2017-02-01
K161360	U2 Total Knee System, PSA Tibial Insert	United Orthopedic Corp.	JWH	Class II	2017-02-01
K161279	Life Spine Metatarsal Hemi Implant	Life Spine	KWD	Class II	2017-02-01
K163542	CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage Case	Datascope Corp.	DSP	Class II	2017-01-31
K163210	Philips CombiDiagnost R90	Philips Medical Systems DMC GmbH	JAA	Class II	2017-01-31
K163170	Capillus 82, Capillus 202, Capillus 272 Pro, 272 Office Pro, Capillus 302, Capillus 312, and Capillus 352	Capillus, LLC	OAP	Class II	2017-01-31
K163122	NobelClinician, DTX Studio implant	Nobel Biocare AB	LLZ	Class II	2017-01-31
K162381	HG PRO XP Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs	Healthy Glove Co., Ltd.	LZA	Class I	2017-01-31
K162055	Acclarix LX8 Diagnostic Ultrasound System	Edan Instruments, Inc.	IYN	Class II	2017-01-31
K161949	OsteoCool V-3 RF Ablation System	Baylis Medical Co., Inc.	GEI	Class II	2017-01-31
K161158	IDS-iSYS Intact PTHN	Immunodiagnostic Systems Ltd.	CEW	Class II	2017-01-31
K160471	Medline Non-Surgical Isolation Gown-	MEDLINE INDUSTRIES, LP - Northfield	FYC	Class II	2017-01-31
K163058	Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle	Boston Scientific Corporation	ODG	Class II	2017-01-30
K163004	Radifocus Glidewire Advantage Track	Ashitaka Factory of Terumo Coporation	DQX	Class II	2017-01-30
K162879	Elite Expandable Interbody Fusion Device	Spineology, Inc.	MAX	Class II	2017-01-30
K162390	ET Hybrid Abutment	Hiossen, Inc.	NHA	Class II	2017-01-30
K162098	LED Phototherapy Device	Li-Tek Electronic Technology Corporation	OLP	Class II	2017-01-30
K162034	OBS Electrosurgical Generator (Model: OBS-350A)	Baisheng Medical Co.,Ltd.	GEI	Class II	2017-01-30
K163689	3M Clear Tray Aligner	3M UNITEK Corporation	NXC	Class II	2017-01-27
K163324	nordicBrainEx	NordicNeuroLab AS	LLZ	Class II	2017-01-27
K163312	MAGNETOM Aera and MAGNETOM Skyra with syngo MR E11C - AP02 Software	Siemens Medical Solutions USA, Inc.	LNH	Class II	2017-01-27
K163280	RP Lite 760R	MEGO AFEK AC Ltd.	IRP	Class II	2017-01-27