Cleared Traditional

K160592 - SUPERCATH 6

K160592 is an FDA 510(k) clearance for SUPERCATH 6, manufactured by Togo Medikit Co., Ltd.. The device is a Class 2 General Hospital device with product code FOZ cleared through the Traditional 510(k) pathway after a 164-day FDA review.

K160592 · Togo Medikit Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2016
Decision
164d
Days
Class 2
Risk

K160592 is an FDA 510(k) clearance for the SUPERCATH 6. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Togo Medikit Co., Ltd. (Hyuga City, JP). The FDA issued a Cleared decision on August 12, 2016 after a review of 164 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5200 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Togo Medikit Co., Ltd. devices

FDA 510(k) Submission Details - K160592

510(k) Number K160592 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2016
Decision Date August 12, 2016
Days to Decision 164 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d slower than avg
Panel avg: 129d · This submission: 164d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FOZ Device Classification - Class 2, Special Controls

Product Code FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5200
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

All 300
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K160592.
PowerGlide Pro Midline Catheter
K162377 · C.R. Bard, Inc. · Sep 2016
BioFlo Midline Catheter
K161866 · Navilyst Medical, Inc. · Sep 2016
BD Nexiva and BD Nexiva Diffusics Closed IV Catheter Systems
K161777 · Becton Dickinson Infusion Therapy Systems, Inc. · Aug 2016
ViaValve Safety I.V. Catheter
K160235 · Smiths Medical Asd, Inc. · Jun 2016
PowerGlide Pro Midline Catheter
K153280 · C.R. Bard, Inc. · Jun 2016
AccuCath Intravascular Catheter
K153298 · C.R. Bard, Inc. · Dec 2015