Cleared Traditional

SUPERCATH5 (K140419) - FDA 510(k) Clearance

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

K140419 · Togo Medikit Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

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 135
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K140419.
PowerGlide Pro Midline Catheter
K162377 · C.R. Bard, Inc. · Sep 2016
PowerGlide Pro Midline Catheter
K153280 · C.R. Bard, Inc. · Jun 2016
AccuCath Intravascular Catheter
K153298 · C.R. Bard, Inc. · Dec 2015
POWERGLIDE MIDLINE CATHETER
K133856 · C.R. Bard, Inc. · Jan 2014
POWERGLIDE MIDLINE CATHETER
K121073 · C.R. Bard, Inc. · Jun 2012
MULTI-MED CENTRAL VENOUS CATHETERS (CVCS), WITH AND WITHOUT HEPARIN VANTEX CENTRAL VENOUS CATHETERS (CVCS), WITH HEPARIN
K113565 · Edwards Lifesciences, LLC · May 2012