Cleared Traditional

K942353 - CENTURION UMBILICAL CATHETER

K942353 is the FDA 510(k) clearance for CENTURION UMBILICAL CATHETER by Tri-State Hospital Supply Corp.. It is a Class 2 General Hospital device (product code FOS) cleared through the Traditional 510(k) pathway after a 455-day FDA review.

K942353 · Tri-State Hospital Supply Corp. · General Hospital
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Aug 1995
Decision
455d
Days
Class 2
Risk

K942353 is an FDA 510(k) clearance for the CENTURION UMBILICAL CATHETER. Classified as Catheter, Umbilical Artery (product code FOS), Class II - Special Controls.

Submitted by Tri-State Hospital Supply Corp. (Howell, US). The FDA issued a Cleared decision on August 15, 1995 after a review of 455 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Tri-State Hospital Supply Corp. devices

Submission Details

510(k) Number K942353 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 1994
Decision Date August 15, 1995
Days to Decision 455 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
326d slower than avg
Panel avg: 129d · This submission: 455d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FOS Catheter, Umbilical Artery
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 - FOS Catheter, Umbilical Artery

All 10
Devices cleared under the same product code (FOS) and FDA review panel - the closest regulatory comparables to K942353.
ARGYLE NEO-SERT HYDROPHILIC POLYURETHANE UMBILICAL VESSEL CATHETER INSERTION TRAY
K954300 · Sherwood Medical Co. · Dec 1995
ARGYLE NEO-SERT TRIPLE LUMEN UMBILICAL VESSEL CATHETER
K951738 · Sherwood Medical Co. · Sep 1995
ARGYLE NEO-SERT TRIPLE LUMEN UMBILICAL VESSEL CATHETER INSERTION TRAY
K951737 · Sherwood Medical Co. · Sep 1995
ARGYLE DUAL LUMEN UMBILICAL VESSEL CATHETER
K941814 · Sherwood Medical Co. · Sep 1994
ARGYLE NEO-SERT
K942564 · Sherwood Medical Co. · Aug 1994
BARD UMBILICAL VESSEL CATHETER
K890685 · C.R. Bard, Inc. · Feb 1989