Cleared Traditional

K800990 - TRACH MIST UNIT W/OR WITHOUT ELBOW

K800990 is an FDA 510(k) clearance for TRACH MIST UNIT W/OR WITHOUT ELBOW, manufactured by Airlife, Inc.. The device is a Class 1 Anesthesiology device with product code BYH cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K800990 · Airlife, Inc. · Anesthesiology device
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May 1980
Decision
14d
Days
Class 1
Risk

K800990 is an FDA 510(k) clearance for the TRACH MIST UNIT W/OR WITHOUT ELBOW. Classified as Drain, Tee (water Trap) (product code BYH), Class I - General Controls.

Submitted by Airlife, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 8, 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 868.5995 - 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 Airlife, Inc. devices

FDA 510(k) Submission Details - K800990

510(k) Number K800990 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 1980
Decision Date May 08, 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.

BYH Device Classification - Class 1, General Controls

Product Code BYH Drain, Tee (water Trap)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5995
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - BYH Drain, Tee (water Trap)

All 14
Devices cleared under the same product code (BYH) and FDA review panel - the closest regulatory comparables to K800990.
AQUA TRAP
K834573 · Airlife, Inc. · Mar 1984
MOISTURE TRAP
K820936 · Dhd Medical Products Div. Diemolding Corp. · Apr 1982
SHERWOOD WATER TRAP
K812569 · Sherwood Medical Co. · Sep 1981
MOISTURE TRAP
K792390 · Dhd Medical Products Div. Diemolding Corp. · Dec 1979
DRAINAGE BAG
K790929 · Mem Medical, Inc. · May 1979
AEROSOL EFFUSION SYSTEM #1740
K770771 · Hudson Oxygen Therapy Sales Co. · Jun 1977