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
Combination Product No
PCCP Authorized No
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 Consultant

Mic International
Izumi Maruo

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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

All 429
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
20G x 1.25 NovaCath Secure IV Catheter System, 24G x 0.56 NovaCath Secure IV Catheter System
K160374 · Tangent Medical Technologies, Inc. · Mar 2016