Cleared Traditional

MODIFIED 225/SIMV VOLUME VENTILATOR (K884389) - FDA 510(k) Clearance

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

K884389 · Monaghan Medical Corp. · Anesthesiology device
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Mar 1990
Decision
510d
Days
Class 2
Risk

K884389 is an FDA 510(k) clearance for the MODIFIED 225/SIMV VOLUME VENTILATOR. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Monaghan Medical Corp. (Plattsburgh, US). The FDA issued a Cleared decision on March 12, 1990 after a review of 510 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5895 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Monaghan Medical Corp. devices

Submission Details

510(k) Number K884389 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 1988
Decision Date March 12, 1990
Days to Decision 510 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
370d slower than avg
Panel avg: 140d · This submission: 510d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CBK Ventilator, Continuous, Facility Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5895
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 - CBK Ventilator, Continuous, Facility Use

All 107
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K884389.
7200AE MICROPROCESSOR VENTILATOR W/ENHANCED HARD.
K902506 · Puritan Bennett Corp. · Jan 1991
OHMEDA 7800 ANESTHESIA VENTILATOR SOFTWARE UPDATE
K902084 · Ohmeda Medical · Oct 1990
PURITAN-BENNETT COMPANION 2801 VOLUME VENTILATOR
K897113 · Puritan Bennett Corp. · Mar 1990
MODIFIED PERMCATH TRAY (2ND SUBMISSION)
K895779 · Quinton, Inc. · Dec 1989
PURITAN-BENNETT 7200SPI MICROPROCESSOR VENTILATOR
K893043 · Puritan Bennett Corp. · Aug 1989
ADVENT VENTILATOR
K884793 · Ohmeda Medical · Jun 1989