Cleared Traditional

K832495 - FLYNN SERIES III BAG/MASK UNIT-

K832495 is an FDA 510(k) clearance for FLYNN SERIES III BAG/MASK UNIT-, manufactured by O-Two Systems Intl., Inc.. The device is a Class 2 Anesthesiology device with product code BTM cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K832495 · O-Two Systems Intl., Inc. · Anesthesiology device
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Sep 1983
Decision
64d
Days
Class 2
Risk

K832495 is an FDA 510(k) clearance for the FLYNN SERIES III BAG/MASK UNIT-. Classified as Ventilator, Emergency, Manual (resuscitator) (product code BTM), Class II - Special Controls.

Submitted by O-Two Systems Intl., Inc. (Walker, US). The FDA issued a Cleared decision on September 29, 1983 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5915 - 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 O-Two Systems Intl., Inc. devices

FDA 510(k) Submission Details - K832495

510(k) Number K832495 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1983
Decision Date September 29, 1983
Days to Decision 64 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 140d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTM Device Classification - Class 2, Special Controls

Product Code BTM Ventilator, Emergency, Manual (resuscitator)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5915
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 - BTM Ventilator, Emergency, Manual (resuscitator)

All 126
Devices cleared under the same product code (BTM) and FDA review panel - the closest regulatory comparables to K832495.
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