Cleared Traditional

K893204 - MUC-X

K893204 is the FDA 510(k) clearance for MUC-X by Island Medical. It is a Class 1 Anesthesiology device (product code BSY) cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K893204 · Island Medical · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1989
Decision
36d
Days
Class 1
Risk

K893204 is an FDA 510(k) clearance for the MUC-X. Classified as Catheters, Suction, Tracheobronchial (product code BSY), Class I - General Controls.

Submitted by Island Medical (Fernandina Beach, US). The FDA issued a Cleared decision on June 1, 1989 after a review of 36 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 Island Medical devices

Submission Details

510(k) Number K893204 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 1989
Decision Date June 01, 1989
Days to Decision 36 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
104d faster than avg
Panel avg: 140d · This submission: 36d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 14
Devices cleared under the same product code (BSY) and FDA review panel - the closest regulatory comparables to K893204.
ARGYLE ASPR-CARE CLOSED SUCTION SYSTEM
K934723 · Sherwood Medical Co. · Nov 1993
ARGYLE ASPIR-FLEX SUCTION CATHETER
K925556 · Sherwood Medical Co. · Jul 1993
ARGYLE AERO-JET SUCTION CATHETER
K922148 · Sherwood Medical Co. · Dec 1992
RESPIRONICS SUCTIONEASY
K882017 · Respironics, Inc. · Jul 1988
SUCTION CATHETER KIT
K843076 · Travenol Laboratories, S.A. · Nov 1984
ARGYLE SUCTION CATHETERS
K830709 · Sherwood Medical Co. · Mar 1983