Cleared Traditional

K910908 - MUCAID WITH SUCTION CATHETER AND EXTENS...

K910908 is an FDA 510(k) clearance for MUCAID WITH SUCTION CATHETER AND EXTENS..., manufactured by Vygon Corp.. The device is a Class 1 Anesthesiology device with product code BSY cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K910908 · Vygon Corp. · Anesthesiology device
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May 1991
Decision
76d
Days
Class 1
Risk

K910908 is an FDA 510(k) clearance for the MUCAID WITH SUCTION CATHETER AND EXTENSION TUBING. Classified as Catheters, Suction, Tracheobronchial (product code BSY), Class I - General Controls.

Submitted by Vygon Corp. (New York, US). The FDA issued a Cleared decision on May 20, 1991 after a review of 76 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.6810 - the FDA anesthesiology and respiratory 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 Vygon Corp. devices

FDA 510(k) Submission Details - K910908

510(k) Number K910908 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 1991
Decision Date May 20, 1991
Days to Decision 76 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 140d · This submission: 76d
Pathway characteristics
Predicate-based equivalence.

BSY Device Classification - Class 1, General Controls

Product Code BSY Catheters, Suction, Tracheobronchial
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.6810
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - BSY Catheters, Suction, Tracheobronchial

All 53
Devices cleared under the same product code (BSY) and FDA review panel - the closest regulatory comparables to K910908.
ARGYLE ASPIR-FLEX SUCTION CATHETER
K925556 · Sherwood Medical Co. · Jul 1993
ARGYLE AERO-JET SUCTION CATHETER
K922148 · Sherwood Medical Co. · Dec 1992
STERILE MUCOUS SPECIMEN TRAP, DISPOSABLE
K923098 · Trinity Laboratories, Inc. · Sep 1992
MUCAID
K910909 · Vygon Corp. · May 1991
BUSSE BAC/SHIELD
K902297 · Busse Hospital Disposables, Inc. · Aug 1990
SUCTION CATHETER, STERILE
K902814 · Orion Life Systems, Inc. · Aug 1990