AnapnoGuard 100 Respiratory Guard System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K150157 FDA 510(k)
- FDA Product Code
- BSK FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.5750 FDA 510(k)
- Regulation Number
- 868.5750 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The AnapnoGuard 100 Respiratory Guard System is a tracheal tube inflatable cuff device used for airway management by oral/nasal intubation. It provides continuous endotracheal cuff pressure to protect the lungs and tracheal tissues from infections and tissue injury during mechanical ventilation.
This device is supplied as a single-use system and is regulated under FDA 510K clearance with product code BSK. It is intended for use in anesthesiology settings and is manufactured by Hospitech Respiration Ltd in Petach Tikva, Israel.
Frequently asked questions
What is the AnapnoGuard 100 Respiratory Guard System used for?
The AnapnoGuard 100 is a tracheal tube inflatable cuff device used for airway management during oral/nasal intubation. It maintains continuous endotracheal cuff pressure to protect the lungs and tracheal tissues from infections and tissue injury during mechanical ventilation.
Is the AnapnoGuard 100 a single-use or reusable device?
The AnapnoGuard 100 Respiratory Guard System is supplied as a single-use system, meaning it should be used for one patient procedure and then discarded to ensure safety and prevent cross-contamination.
What are the intended settings for using the AnapnoGuard 100?
This device is intended for use in anesthesiology settings where airway management during mechanical ventilation is required. It is specifically designed for clinical environments where tracheal intubation is performed.
What is the regulatory status of the AnapnoGuard 100?
The AnapnoGuard 100 Respiratory Guard System is regulated under FDA 510K clearance with product code BSK. It has been determined to be substantially equivalent to other devices in this category.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: AnapnoGuard 100 Respiratory Guard System - healthcareequipment.org, Hospitech | home, Hospitech | AG 100s control unit, FDA Browser - Cleared 510 (K) - AnapnoGuard 100 Respiratory Guard ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K150157 | Class II | Active |
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Manufacturer
- Manufacturer
- Hospitech Respiration Ltd
- FDA Applicant
- Hospitech Respiration , Ltd.
Sources (1)
- FDA 510(k) K150157 24 fields · synced Sep 19, 2026