Cleared Traditional

K140419 - SUPERCATH5

K140419 is an FDA 510(k) clearance for SUPERCATH5, 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 83-day FDA review.

K140419 · Togo Medikit Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
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May 2014
Decision
83d
Days
Class 2
Risk

K140419 is an FDA 510(k) clearance for the SUPERCATH5. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Togo Medikit Co., Ltd. (Bunkyo-Ku, JP). The FDA issued a Cleared decision on May 12, 2014 after a review of 83 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Togo Medikit Co., Ltd. devices

FDA 510(k) Submission Details - K140419

510(k) Number K140419 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 2014
Decision Date May 12, 2014
Days to Decision 83 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
46d faster than avg
Panel avg: 129d · This submission: 83d
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
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