Cleared Traditional

SUPERCATH 5 (26G) (K172496) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K172496 · Togo Medikit Co., Ltd. · General Hospital
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Mar 2018
Decision
217d
Days
Class 2
Risk

K172496 is an FDA 510(k) clearance for the SUPERCATH 5 (26G). 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 March 23, 2018 after a review of 217 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

Submission Details

510(k) Number K172496 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 2017
Decision Date March 23, 2018
Days to Decision 217 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
88d slower than avg
Panel avg: 129d · This submission: 217d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 133
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K172496.
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BD Cathena Safety IV Catheter
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BD Intima II PLUS Closed IV Catheter System
K172204 · Becton, Dickinson and Company · Aug 2017
BD Nexiva Closed IV Catheter System (Single Port) with MaxZero Needleless Connector
K170336 · Becton, Dickinson and Company · Mar 2017