Cleared Traditional

K111640 - PRECISION FLOW - HELIOX

K111640 is an FDA 510(k) clearance for PRECISION FLOW - HELIOX, manufactured by Vapotherm, Inc.. The device is a Class 2 Anesthesiology device with product code BTT cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K111640 · Vapotherm, Inc. · Anesthesiology device
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Oct 2011
Decision
116d
Days
Class 2
Risk

K111640 is an FDA 510(k) clearance for the PRECISION FLOW(R) - HELIOX. Classified as Humidifier, Respiratory Gas, (direct Patient Interface) (product code BTT), Class II - Special Controls.

Submitted by Vapotherm, Inc. (Stevensville, US). The FDA issued a Cleared decision on October 7, 2011 after a review of 116 days - within the typical 510(k) review window.

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 Vapotherm, Inc. devices

FDA 510(k) Submission Details - K111640

510(k) Number K111640 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 2011
Decision Date October 07, 2011
Days to Decision 116 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 140d · This submission: 116d
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 110
Devices cleared under the same product code (BTT) and FDA review panel - the closest regulatory comparables to K111640.
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THERA- HEAT HEATED HUMIDIFIER, MODEL RC70000, RC70072, RC70075, RC70077, RC70012
K092256 · Smiths Medical Asd, Inc. · Oct 2010
RESPIRATORY HUMIDIFIER , HEATED DELIVERY SYSTEM, ADAPTOR, MODELS MR880, RT241, 900MR441
K100554 · Fisher &Paykel Healthcare , Ltd. · May 2010
AIRVO SERIES HUMIDIFIERS
K092846 · Fisher &Paykel Healthcare , Ltd. · Jan 2010