Cleared Traditional

MARPAC MESSENGER MODEL #501 (K041485) - FDA 510(k) Clearance

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

K041485 · Marpac, Inc. · Anesthesiology device
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Aug 2004
Decision
59d
Days
Class 2
Risk

K041485 is an FDA 510(k) clearance for the MARPAC MESSENGER MODEL #501. Classified as Tube Tracheostomy And Tube Cuff (product code JOH), Class II - Special Controls.

Submitted by Marpac, Inc. (Albuquerque, US). The FDA issued a Cleared decision on August 2, 2004 after a review of 59 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5800 - 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 Marpac, Inc. devices

Submission Details

510(k) Number K041485 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 2004
Decision Date August 02, 2004
Days to Decision 59 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 140d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JOH Tube Tracheostomy And Tube Cuff
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5800
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 Anesthesiology devices follow this clearance model.

Regulatory Peers - JOH Tube Tracheostomy And Tube Cuff

All 20
Devices cleared under the same product code (JOH) and FDA review panel - the closest regulatory comparables to K041485.
SHILEY NEONATAL TRACHEOSTOMY TUBE CUFFLESS, SHILEY PEDIATRIC TRACHEOSTOMY TUBE CUFFLESS, SHILEY PEDIATRIC TRACHEOSTOMY T
K122531 · Covidien · Oct 2012
CIAGLIA BLUE DOLPHIN BALLOON PERCUTANEOUS TRACHEOSTOMY INTRODUCER, MODEL: MULTIPLE, PREFIX C-PTBS
K093469 · Cook, Inc. · Jan 2010
CIAGLIA BLUE DOLPHIN (TM) BALLOON PERCUTANEOUS TRACHEOSTOMY INTRODUCER
K072148 · Cook, Inc. · Oct 2007
CIAGLIA CHEETAH PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET
K041044 · Cook, Inc. · Jul 2004
SHILEY SPECIALIZED TRACHEOSTOMY TUBE
K903435 · Shiley, Inc. · Oct 1990
SHILEY SPECIALIZED TRACHEOSTOMY TUBE
K890194 · Shiley, Inc. · Jul 1989