Cleared Traditional

VYGON DOUBLE LUMEN UMBILICAL CATHETER (K981630) - FDA 510(k) Clearance

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

K981630 · Schiff & Co. · General Hospital
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Oct 1998
Decision
147d
Days
Class 2
Risk

K981630 is an FDA 510(k) clearance for the VYGON DOUBLE LUMEN UMBILICAL CATHETER. Classified as Catheter, Umbilical Artery (product code FOS), Class II - Special Controls.

Submitted by Schiff & Co. (West Cadwell, US). The FDA issued a Cleared decision on October 1, 1998 after a review of 147 days - within the typical 510(k) review window.

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 Schiff & Co. devices

Submission Details

510(k) Number K981630 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 1998
Decision Date October 01, 1998
Days to Decision 147 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
18d slower than avg
Panel avg: 129d · This submission: 147d
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 K981630.
Umbilical Vessels Catheter
K201697 · Haolang Medical USA Corporation · May 2021
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