Cleared Traditional

K822635 - 225 S.I.M.V. VENTILATOR

K822635 is an FDA 510(k) clearance for 225 S.I.M.V. VENTILATOR, manufactured by Monaghan Medical Corp.. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Traditional 510(k) pathway after a 77-day FDA review.

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

FDA 510(k) Submission Details - K822635

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
Combination Product No
PCCP Authorized No
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.

CBK Device Classification - Class 2, Special Controls

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 250
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K822635.
PZ-800 VOLUME VENTILATOR
K822835 · Narco Scientific · Sep 1983
VENTILATOR #1
K830488 · Ohio Medical Products · Sep 1983
VOLUME VENTILATOR
K823858 · Puritan Bennett Corp. · Dec 1982
OHIO CPU-1 INTENSIVE CARE VENTILATOR
K822888 · Ohio Medical Products · Nov 1982
ABT 4000 VENTILATOR
K822233 · Kontron Instruments, Inc. · Aug 1982
OHIO 7000 ELECTRONIC ANESTHESIA VENTIL.
K821376 · Ohio Medical Products · Jun 1982