Cleared Traditional

K760566 - PREFILLED HUMIDIFIER

K760566 is the FDA 510(k) clearance for PREFILLED HUMIDIFIER by Foregger Air Products & Chem., Inc.. It is a Class 2 Anesthesiology device (product code BTT) cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K760566 · Foregger Air Products & Chem., Inc. · Anesthesiology device
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Oct 1976
Decision
43d
Days
Class 2
Risk

K760566 is an FDA 510(k) clearance for the PREFILLED HUMIDIFIER. Classified as Humidifier, Respiratory Gas, (direct Patient Interface) (product code BTT), Class II - Special Controls.

Submitted by Foregger Air Products & Chem., Inc. (Mchenry, US). The FDA issued a Cleared decision on October 15, 1976 after a review of 43 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 Foregger Air Products & Chem., Inc. devices

Submission Details

510(k) Number K760566 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 1976
Decision Date October 15, 1976
Days to Decision 43 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 140d · This submission: 43d
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 76
Devices cleared under the same product code (BTT) and FDA review panel - the closest regulatory comparables to K760566.
VENTILATOR SET - CODE 2C7109
K770249 · Travenol Laboratories, S.A. · Feb 1977
HUMIDIFIER-CASCADE II
K760923 · Puritan Bennett Corp. · Nov 1976
DISPOSABLE HUMIDIFIER
K760938 · Travenol Laboratories, S.A. · Nov 1976
U-MID PREFILLED HUMIDIFIER (500CC)
K760584 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1976
U-MID PREFILLED HUMIDIFIER (300CC)
K760587 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1976