Cleared Traditional

K780216 - LIFESAVER

K780216 is the FDA 510(k) clearance for LIFESAVER by Hudson Oxygen Therapy Sales Co.. It is a Class 2 Anesthesiology device (product code BTM) cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K780216 · Hudson Oxygen Therapy Sales Co. · Anesthesiology device
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Mar 1978
Decision
32d
Days
Class 2
Risk

K780216 is an FDA 510(k) clearance for the LIFESAVER, MANUAL #5160. Classified as Ventilator, Emergency, Manual (resuscitator) (product code BTM), Class II - Special Controls.

Submitted by Hudson Oxygen Therapy Sales Co. (Mchenry, US). The FDA issued a Cleared decision on March 14, 1978 after a review of 32 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 Hudson Oxygen Therapy Sales Co. devices

Submission Details

510(k) Number K780216 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 1978
Decision Date March 14, 1978
Days to Decision 32 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
108d faster than avg
Panel avg: 140d · This submission: 32d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.