Cleared Traditional

OASIS HUMIDIFIER (K964653) - FDA 510(k) Clearance

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

K964653 · Respironics, Inc. · Anesthesiology device

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Feb 1997

Decision

86d

Days

Class 2

Risk

K964653 is an FDA 510(k) clearance for the OASIS HUMIDIFIER. Classified as Humidifier, Respiratory Gas, (direct Patient Interface) (product code BTT), Class II - Special Controls.

Submitted by Respironics, Inc. (Murrysville, US). The FDA issued a Cleared decision on February 14, 1997 after a review of 86 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 Respironics, Inc. devices

Submission Details

510(k) Number	K964653 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 20, 1996
Decision Date	February 14, 1997
Days to Decision	86 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

54d faster than avg

Panel avg: 140d · This submission: 86d

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 50

Devices cleared under the same product code (BTT) and FDA review panel - the closest regulatory comparables to K964653.

TNI softFlow 50

K180474 · Tni Medical AG · Oct 2018

H2 HEATED HUMIDIFIER

K030090 · Respironics, Inc. · Jan 2003

RESPIRONICS HEATED HUMIDIFIER

K012633 · Respironics, Inc. · Feb 2002

HUMIDIFIER

K945782 · Respironics, Inc. · Mar 1996

STERILE WATER FOR INHALATION USP 2D0799

K851940 · Travenol Laboratories, S.A. · Jun 1985

BIRD HEATED HUMIDIFIER 3201

K842523 · 3M Company · Jul 1984

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K964653

Respironics, Inc.

Murrysville, PA · US

FRANCIS X DOBSCHA

Regulatory profile

172 submissions 168 cleared

98% clearance rate · Active in Anesthesiology

Data Intelligence Layer

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Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

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