Cleared Traditional

HEATED RESPIRATORY HUMIDIFIER HC100 (K915460) - FDA 510(k) Clearance

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

K915460 · Fisher & Paykel Electronics , Ltd. · Anesthesiology device
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Jan 1993
Decision
408d
Days
Class 2
Risk

K915460 is an FDA 510(k) clearance for the HEATED RESPIRATORY HUMIDIFIER HC100. Classified as Humidifier, Respiratory Gas, (direct Patient Interface) (product code BTT), Class II - Special Controls.

Submitted by Fisher & Paykel Electronics , Ltd. (Auckland, New Zealand, NZ). The FDA issued a Cleared decision on January 15, 1993 after a review of 408 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Fisher & Paykel Electronics , Ltd. devices

Submission Details

510(k) Number K915460 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 1991
Decision Date January 15, 1993
Days to Decision 408 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
268d slower than avg
Panel avg: 140d · This submission: 408d
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 56
Devices cleared under the same product code (BTT) and FDA review panel - the closest regulatory comparables to K915460.
OASIS HUMIDIFIER
K964653 · Respironics, Inc. · Feb 1997
HUMIDIFIER
K945782 · Respironics, Inc. · Mar 1996
PURITAN-BENNETT CASCADE I SERIES HUMIDIFIER MODIFICATION
K936000 · Puritan Bennett Corp. · Aug 1994
STERILE WATER FOR INHALATION USP 2D0799
K851940 · Travenol Laboratories, S.A. · Jun 1985
BIRD HEATED HUMIDIFIER 3201
K842523 · 3M Company · Jul 1984
2M8101 HEATED LIQUID LEVEL CONTROLLER
K802144 · Travenol Laboratories, S.A. · Sep 1980