Respironics BiPAP Remote Control Unit
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K905540 FDA 510(k)
- FDA Product Code
- BZD FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.5905 FDA 510(k)
- Regulation Number
- 868.5905 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
A ventilator, non-continuous (respirator) accessory designed to provide remote control functionality for BiPAP systems. This device enables adjustments to pressure support and other ventilatory parameters from a distance, enhancing patient management and operational flexibility in clinical settings. It interfaces with BiPAP ventilators to facilitate adjustments without direct physical access to the primary unit.
The Respironics BiPAP Remote Control Unit is intended for use in hospital or clinical environments where patient monitoring and ventilatory support are required. Supplied as a reusable device, it is not sterile and must be cleaned and maintained according to manufacturer guidelines. The unit operates within the regulatory framework of the FDA under 510(k) clearance (K905540) and adheres to classification BZD. No MRI safety information is specified, and its use is restricted to compatible BiPAP systems as defined by the manufacturer.
Frequently asked questions
What is the Respironics BiPAP Remote Control Unit used for?
The Respironics BiPAP Remote Control Unit is designed as an accessory for BiPAP ventilators to provide remote control functionality. It allows healthcare providers to adjust ventilatory parameters, such as pressure support, without needing direct physical access to the primary ventilator unit. This enhances patient management flexibility, particularly in clinical or hospital environments where real-time adjustments may be required.
Is the Respironics BiPAP Remote Control Unit single-use or reusable?
The Respironics BiPAP Remote Control Unit is a reusable device. It is not intended for single-use and must be cleaned and maintained according to the manufacturer’s guidelines to ensure proper functionality and hygiene in clinical settings.
Is the Respironics BiPAP Remote Control Unit sterile?
No, the Respironics BiPAP Remote Control Unit is not sterile. It is supplied as a reusable device and must be cleaned and maintained as part of routine care protocols to prevent contamination and ensure safe use in clinical environments.
Which BiPAP systems is the Remote Control Unit compatible with?
The Respironics BiPAP Remote Control Unit is specifically designed for use with compatible BiPAP ventilators as defined by Respironics. It is not universally compatible with all BiPAP models, so verification of compatibility with the intended ventilator system is essential before use.
What regulatory pathway does the Respironics BiPAP Remote Control Unit follow?
The Respironics BiPAP Remote Control Unit has been cleared by the FDA under the 510(k) pathway (K905540) and is classified under product code BZD. This clearance indicates that the device is considered substantially equivalent to a legally marketed predicate device and adheres to FDA regulations for ventilator accessories.
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: RESPIRONICS BIPAP SERVICE MANUAL Pdf Download | ManualsLib, K905540 FDA 510(k) - RESPIRONICS BIPAP REMOTE CONTROL UNIT, Respironics CPAP & BiPAP Machine Parts - sleeprestfully.com, RESPIRONICS BIPAP REMOTE CONTROL UNIT - Innolitics, Respironics BiPAP Vision Service Manual | PDF | Analog To Digital ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K905540 | Class II | Active |
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Manufacturer
- Manufacturer
- Respironics, Inc.
Sources (1)
- FDA 510(k) K905540 24 fields · synced Oct 1, 2026