Cleared Traditional

K013486 - VAPOTHERM 2000H

K013486 is an FDA 510(k) clearance for VAPOTHERM 2000H, 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 588-day FDA review.

K013486 · Vapotherm, Inc. · Anesthesiology device
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May 2003
Decision
588d
Days
Class 2
Risk

K013486 is an FDA 510(k) clearance for the VAPOTHERM 2000H. Classified as Humidifier, Respiratory Gas, (direct Patient Interface) (product code BTT), Class II - Special Controls.

Submitted by Vapotherm, Inc. (Mccordsville, US). The FDA issued a Cleared decision on May 30, 2003 after a review of 588 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 Vapotherm, Inc. devices

FDA 510(k) Submission Details - K013486

510(k) Number K013486 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 2001
Decision Date May 30, 2003
Days to Decision 588 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
448d slower than avg
Panel avg: 140d · This submission: 588d
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 K013486.
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K012633 · Respironics, Inc. · Feb 2002
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K003973 · Fisher &Paykel Healthcare , Ltd. · Jun 2001