Cleared Traditional

225 S.I.M.V. VENTILATOR (K822635) - FDA 510(k) Clearance

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

K822635 · Monaghan Medical Corp. · Anesthesiology device
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Nov 1982
Decision
77d
Days
Class 2
Risk

K822635 is an FDA 510(k) clearance for the 225 S.I.M.V. VENTILATOR. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Monaghan Medical Corp. (Walker, US). The FDA issued a Cleared decision on November 16, 1982 after a review of 77 days - a notably fast clearance cycle.

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: 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 Monaghan Medical Corp. devices

Submission Details

510(k) Number K822635 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1982
Decision Date November 16, 1982
Days to Decision 77 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 140d · This submission: 77d
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 98
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K822635.
COMPANION 2500 PORTABLE VOLUME VENTILATOR
K862810 · Puritan Bennett Corp. · Sep 1986
7200 MICROPROCESS VENT SYS/MODEL 7202 DISPLAY OPT
K862604 · Puritan Bennett Corp. · Aug 1986
OHMEDA 7000 ELECTRONIC ANESTHESIA VENTILATOR
K851509 · Ohmeda Medical · Jul 1985
BABYBIRD 2 VENTILATOR
K820132 · 3M Company · Jan 1982
HEWLETT-PACKARD VENTILATOR
K810893 · Hewlett-Packard Co. · Jun 1981