Cleared Traditional

K150157 - AnapnoGuard 100 Respiratory Guard System

K150157 is an FDA 510(k) clearance for AnapnoGuard 100 Respiratory Guard System, manufactured by Hospitech Respiration , Ltd.. The device is a Class 2 Anesthesiology device with product code BSK cleared through the Traditional 510(k) pathway after a 389-day FDA review.

K150157 · Hospitech Respiration , Ltd. · Anesthesiology device
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Feb 2016
Decision
389d
Days
Class 2
Risk

K150157 is an FDA 510(k) clearance for the AnapnoGuard 100 Respiratory Guard System. Classified as Cuff, Tracheal Tube, Inflatable (product code BSK), Class II - Special Controls.

Submitted by Hospitech Respiration , Ltd. (Petach Tikva, IL). The FDA issued a Cleared decision on February 16, 2016 after a review of 389 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5750 - 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. Elevated predicate reliance profile. 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

FDA 510(k) Submission Details - K150157

510(k) Number K150157 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 2015
Decision Date February 16, 2016
Days to Decision 389 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
249d slower than avg
Panel avg: 140d · This submission: 389d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BSK Device Classification - Class 2, Special Controls

Product Code BSK Cuff, Tracheal Tube, Inflatable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5750
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 Consultant

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Yoram Levy

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - BSK Cuff, Tracheal Tube, Inflatable

All 29
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AG GUFFILL
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