Cleared Traditional

K093126 - ANAPNOGUARD ENDOTRACHEAL TUBE (FDA 510(k) Clearance)

Class I Anesthesiology device.

K093126 · Hospitech Respiration , Ltd. · Anesthesiology device
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Mar 2010
Decision
151d
Days
Class 1
Risk

K093126 is an FDA 510(k) clearance for the ANAPNOGUARD ENDOTRACHEAL TUBE. Classified as Dropper, Ether (product code BTP), Class I - General Controls.

Submitted by Hospitech Respiration , Ltd. (Binyamina, IL). The FDA issued a Cleared decision on March 2, 2010 after a review of 151 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5420 - 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 Hospitech Respiration , Ltd. devices

Submission Details

510(k) Number K093126 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 2009
Decision Date March 02, 2010
Days to Decision 151 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
12d slower than avg
Panel avg: 139d · This submission: 151d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BTP Dropper, Ether
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5420
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.