Cleared Traditional

NEO-CARE DUAL LUMEN UMBILICAL CATHETER (K963972) - FDA 510(k) Clearance

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

K963972 · Klein-Baker Medical, Inc. · General Hospital
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Dec 1996
Decision
82d
Days
Class 2
Risk

K963972 is an FDA 510(k) clearance for the NEO-CARE DUAL LUMEN UMBILICAL CATHETER. Classified as Catheter, Umbilical Artery (product code FOS), Class II - Special Controls.

Submitted by Klein-Baker Medical, Inc. (San Antonio, US). The FDA issued a Cleared decision on December 24, 1996 after a review of 82 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 Klein-Baker Medical, Inc. devices

Submission Details

510(k) Number K963972 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 1996
Decision Date December 24, 1996
Days to Decision 82 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
47d faster than avg
Panel avg: 129d · This submission: 82d
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 K963972.
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