Cleared Traditional

K802231 - AIR VIVA II

K802231 is an FDA 510(k) clearance for AIR VIVA II, manufactured by General Medical Co.. The device is a Class 2 Anesthesiology device with product code BTM cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K802231 · General Medical Co. · Anesthesiology device
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Oct 1980
Decision
25d
Days
Class 2
Risk

K802231 is an FDA 510(k) clearance for the AIR VIVA II. Classified as Ventilator, Emergency, Manual (resuscitator) (product code BTM), Class II - Special Controls.

Submitted by General Medical Co. (Mchenry, US). The FDA issued a Cleared decision on October 10, 1980 after a review of 25 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 General Medical Co. devices

FDA 510(k) Submission Details - K802231

510(k) Number K802231 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 1980
Decision Date October 10, 1980
Days to Decision 25 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
115d faster than avg
Panel avg: 140d · This submission: 25d
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 132
Devices cleared under the same product code (BTM) and FDA review panel - the closest regulatory comparables to K802231.
SIEMENS-ELEMA AB AGA REVIVATOR
K822213 · Siemens Elema AB · Oct 1982
RESUSCITATION CIRCUIT
K812273 · Vital Signs, Inc. · Aug 1981
PMR-2 PURITAN MANUAL RESUSCITATOR
K802813 · Puritan Bennett Corp. · Dec 1980
AIR-SHIELDS RESUSCITATORS
K792118 · Narco Air-Shields · Nov 1979
RESUSCI-BAG-VALVE
K791468 · Concept, Inc. · Aug 1979
LIFESAVER, MANUAL #5160
K780216 · Hudson Oxygen Therapy Sales Co. · Mar 1978