Cleared Traditional

HYMIDIFIER (K780088) - FDA 510(k) Clearance

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

K780088 · 3M Company · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1978
Decision
20d
Days
Class 2
Risk

K780088 is an FDA 510(k) clearance for the HYMIDIFIER. Classified as Humidifier, Respiratory Gas, (direct Patient Interface) (product code BTT), Class II - Special Controls.

Submitted by 3M Company (White City, US). The FDA issued a Cleared decision on February 2, 1978 after a review of 20 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 3M Company devices

Submission Details

510(k) Number K780088 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 1978
Decision Date February 02, 1978
Days to Decision 20 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
120d faster than avg
Panel avg: 140d · This submission: 20d
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 55
Devices cleared under the same product code (BTT) and FDA review panel - the closest regulatory comparables to K780088.
CONTINUOUS FEED VALVE 2D9024
K781468 · Travenol Laboratories, S.A. · Sep 1978
RESPIRATORY THERAPY SOLUTIONS - FLEXIBLE
K780381 · Travenol Laboratories, S.A. · May 1978
RESPIRATORY THERAPY SOLUTIONS - FLEXIBLE
K780385 · Travenol Laboratories, S.A. · May 1978
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