Cleared Traditional

K771022 - CATHETER

K771022 is an FDA 510(k) clearance for CATHETER, manufactured by Axiom Medical, Inc.. The device is a Class 2 General Hospital device with product code FOS cleared through the Traditional 510(k) pathway after a 176-day FDA review.

K771022 · Axiom Medical, Inc. · General Hospital
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Nov 1977
Decision
176d
Days
Class 2
Risk

K771022 is an FDA 510(k) clearance for the CATHETER, UMBILICAR ARTERY. Classified as Catheter, Umbilical Artery (product code FOS), Class II - Special Controls.

Submitted by Axiom Medical, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 29, 1977 after a review of 176 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 Axiom Medical, Inc. devices

FDA 510(k) Submission Details - K771022

510(k) Number K771022 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 1977
Decision Date November 29, 1977
Days to Decision 176 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
47d slower than avg
Panel avg: 129d · This submission: 176d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FOS Device Classification - Class 2, Special Controls

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 21
Devices cleared under the same product code (FOS) and FDA review panel - the closest regulatory comparables to K771022.
ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETER
K850884 · Sherwood Medical Co. · Oct 1985
XRO UMBILICAL CATHETER-CODE 270
K851005 · Vygon Corp. · May 1985
INTRAVASCULAR CATHETER
K831988 · C.R. Bard, Inc. · Nov 1983
CATHETER, UMBILICAL, VICRA
K771891 · Travenol Laboratories, S.A. · Nov 1977
CATHETER, UMBILICAL ARTERY
K760966 · Sherwood Medical Industries · Jan 1977