Cleared Special

K070056 - VAPOTHERM MODEL# 2000I AND 2000H

K070056 is an FDA 510(k) clearance for VAPOTHERM MODEL# 2000I AND 2000H, manufactured by Vapotherm, Inc.. The device is a Class 2 Anesthesiology device with product code BTT cleared through the Special 510(k) pathway after a 98-day FDA review.

K070056 · Vapotherm, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2007
Decision
98d
Days
Class 2
Risk

K070056 is an FDA 510(k) clearance for the VAPOTHERM MODEL# 2000I AND 2000H. Classified as Humidifier, Respiratory Gas, (direct Patient Interface) (product code BTT), Class II - Special Controls.

Submitted by Vapotherm, Inc. (Washington, US). The FDA issued a Cleared decision on April 13, 2007 after a review of 98 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Vapotherm, Inc. devices

FDA 510(k) Submission Details - K070056

510(k) Number K070056 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 2007
Decision Date April 13, 2007
Days to Decision 98 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 140d · This submission: 98d
Pathway characteristics
Modification to existing cleared device.

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 K070056.
RESPIRATORY HUMIDIFIER, MODEL MR850
K073706 · Fisher &Paykel Healthcare , Ltd. · Mar 2008
THERA-HEAT HEATED HUMIDIFIER AND ADULT DUAL AND SINGLE LIMB HEATED WIRE VENTILATOR BREATHING CIRCUITS
K071958 · Smiths Medical Asd, Inc. · Nov 2007
CHONCHA THERM NEPTUNE HEATED HUMIFIER, CHONCHA THERM NEPTUNE HEATED HUMIFIER (REMANUFACTURER), MODEL# 425-00,425-00R
K063758 · Teleflex Medical · Apr 2007
HUMIDCARE HEATED HUMIDIFIER, MODEL 9S-004
K062664 · Apex Medical Corp. · Dec 2006
COMFORT FLO HUMIDIFICATION SYSTEM AND NASAL CANNULA
K061736 · Teleflex Medical · Aug 2006
AQUINOX
K050314 · Smiths Medical Asd, Inc. · Feb 2005