Cleared Traditional

VENTILATOR SET (K800056) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K800056 · Abbott Laboratories · Anesthesiology device
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Jan 1980
Decision
14d
Days
Class 2
Risk

K800056 is an FDA 510(k) clearance for the VENTILATOR SET. Classified as Humidifier, Respiratory Gas, (direct Patient Interface) (product code BTT), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on January 24, 1980 after a review of 14 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 Abbott Laboratories devices

Submission Details

510(k) Number K800056 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 1980
Decision Date January 24, 1980
Days to Decision 14 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
126d faster than avg
Panel avg: 140d · This submission: 14d
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 52
Devices cleared under the same product code (BTT) and FDA review panel - the closest regulatory comparables to K800056.
2M8101 HEATED LIQUID LEVEL CONTROLLER
K802144 · Travenol Laboratories, S.A. · Sep 1980
2C 7140 HEATED HUMIDIFER CANNISTER
K802145 · Travenol Laboratories, S.A. · Sep 1980
STERILE WATER & SALINE IN PLASTIC BTL.
K800753 · Travenol Laboratories, S.A. · Apr 1980
STERILE WATER FOR RESPIRATORY THERAPY
K791683 · Abbott Laboratories · Sep 1979
OXYGEN HUMIDIFIER KIT
K790731 · Abbott Laboratories · May 1979
CONTINUOUS FEED VALVE 2D9024
K781468 · Travenol Laboratories, S.A. · Sep 1978