Cleared Traditional

K780385 - RESPIRATORY THERAPY SOLUTIONS - FLEXIBLE

K780385 is the FDA 510(k) clearance for RESPIRATORY THERAPY SOLUTIONS - FLEXIBLE by Travenol Laboratories, S.A.. It is a Class 2 Anesthesiology device (product code BTT) cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K780385 · Travenol Laboratories, S.A. · Anesthesiology device
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May 1978
Decision
67d
Days
Class 2
Risk

K780385 is an FDA 510(k) clearance for the RESPIRATORY THERAPY SOLUTIONS - FLEXIBLE. Classified as Humidifier, Respiratory Gas, (direct Patient Interface) (product code BTT), Class II - Special Controls.

Submitted by Travenol Laboratories, S.A. (Mchenry, US). The FDA issued a Cleared decision on May 16, 1978 after a review of 67 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5450 - 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 Travenol Laboratories, S.A. devices

Submission Details

510(k) Number K780385 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1978
Decision Date May 16, 1978
Days to Decision 67 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
73d faster than avg
Panel avg: 140d · This submission: 67d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BTT Humidifier, Respiratory Gas, (direct Patient Interface)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5450
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 - BTT Humidifier, Respiratory Gas, (direct Patient Interface)

All 81
Devices cleared under the same product code (BTT) and FDA review panel - the closest regulatory comparables to K780385.
OXYGEN HUMIDIFIER KIT
K790731 · Abbott Laboratories · May 1979
CONTINUOUS FEED VALVE 2D9024
K781468 · Travenol Laboratories, S.A. · Sep 1978
RESPIRATORY THERAPY SOLUTIONS - FLEXIBLE
K780381 · Travenol Laboratories, S.A. · May 1978
HYMIDIFIER
K780088 · 3M Company · Feb 1978
VENTILATOR SET - CODE 2C7109
K770249 · Travenol Laboratories, S.A. · Feb 1977
HUMIDIFIER-CASCADE II
K760923 · Puritan Bennett Corp. · Nov 1976