Cleared Traditional

SUPERCATH Z3V (K112290) - FDA 510(k) Clearance

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

K112290 · Togo Medikit Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2012
Decision
251d
Days
Class 2
Risk

K112290 is an FDA 510(k) clearance for the SUPERCATH Z3V. 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, Tokyo, JP). The FDA issued a Cleared decision on April 16, 2012 after a review of 251 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 K112290 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 2011
Decision Date April 16, 2012
Days to Decision 251 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
122d slower than avg
Panel avg: 129d · This submission: 251d
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 K112290.
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
BD INSYTE AUTOGUARD BC
K110443 · Becton, Dickinson & CO · Jul 2011
SPECTRUM TURBO-JECT PICC SET
K100974 · Cook Incorporated · May 2010
MULTI-MED CENTRAL VENOUS CATHETERS, MODELS: M3720HKIC, M4820HKIC
K091709 · Edwards Lifesciences, LLC · Oct 2009