Cleared Traditional

K000401 - VAPOTHERM

K000401 is an FDA 510(k) clearance for VAPOTHERM, 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 199-day FDA review.

K000401 · Vapotherm, Inc. · Anesthesiology device
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Aug 2000
Decision
199d
Days
Class 2
Risk

K000401 is an FDA 510(k) clearance for the VAPOTHERM, MODEL 2000I. Classified as Humidifier, Respiratory Gas, (direct Patient Interface) (product code BTT), Class II - Special Controls.

Submitted by Vapotherm, Inc. (Annapolis, US). The FDA issued a Cleared decision on August 24, 2000 after a review of 199 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 Vapotherm, Inc. devices

FDA 510(k) Submission Details - K000401

510(k) Number K000401 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 2000
Decision Date August 24, 2000
Days to Decision 199 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
59d slower than avg
Panel avg: 140d · This submission: 199d
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 K000401.
RESPIRATORY HUMIDIFIER, MODEL HC150
K003973 · Fisher &Paykel Healthcare , Ltd. · Jun 2001
INVACARE PASSOVER HUMIDIFIER MODEL ISP9700
K003561 · Invacare Corp. · Apr 2001
BREAS HA50 HUMIDIFIER, MODEL HA50
K002454 · Vital Signs, Inc. · Mar 2001
CLOUD 1 HUMIDIFICATION SYSTEM
K983862 · Respiratory Support Products, Inc. · May 1999
AIRLIFE BUBBLE HUMIDIFER, MODEL 002003 AND 002006
K991484 · Allegiance Healthcare Corp. · May 1999
RESPIRATORY HUMIDIFIER, MODEL # MR850
K983112 · Fisher &Paykel Healthcare , Ltd. · Nov 1998