Cleared Traditional

K914686 - THERMO-FLOW SET

K914686 is an FDA 510(k) clearance for THERMO-FLOW SET, manufactured by Inhalation Plastics. The device is a Class 2 Anesthesiology device with product code BTT cleared through the Traditional 510(k) pathway after a 180-day FDA review.

K914686 · Inhalation Plastics · Anesthesiology device
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Apr 1992
Decision
180d
Days
Class 2
Risk

K914686 is an FDA 510(k) clearance for the THERMO-FLOW SET. Classified as Humidifier, Respiratory Gas, (direct Patient Interface) (product code BTT), Class II - Special Controls.

Submitted by Inhalation Plastics (Chicago, US). The FDA issued a Cleared decision on April 15, 1992 after a review of 180 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Inhalation Plastics devices

FDA 510(k) Submission Details - K914686

510(k) Number K914686 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 1991
Decision Date April 15, 1992
Days to Decision 180 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
40d slower than avg
Panel avg: 140d · This submission: 180d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTT Device Classification - Class 2, Special Controls

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 166
Devices cleared under the same product code (BTT) and FDA review panel - the closest regulatory comparables to K914686.
MR290 HUMIDIFICATION CHAMBER SINGLE USE
K934140 · Fisher & Paykel Electronics , Ltd. · Jan 1994
HEATED RESPIRATORY HUMIDIFIER HC100
K915460 · Fisher & Paykel Electronics , Ltd. · Jan 1993
MODELS MR410 & MR480 RESPIRATORY HUMIDIFIER/ACCESS
K913367 · Fisher & Paykel Electronics , Ltd. · Jun 1992
OPTI-MOL FILTERED PUNCTURE PIN
K920306 · Automatic Liquid Packaging, Inc. · Apr 1992
MODELS MR700/MR720/MR730 DUAL SERVO RESP HUMID ACC
K913368 · Fisher & Paykel Electronics , Ltd. · Jan 1992
OPTIMOL RESPIRATORY HUMIDIFICATION SYSTEM
K911770 · Automatic Liquid Packaging, Inc. · Oct 1991