Bipap A 40 Ventilatory Support System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K121623 FDA 510(k)
- FDA Product Code
- MNT FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.5895 FDA 510(k)
- Regulation Number
- 868.5895 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The BiPAP A40 Ventilatory Support System is a non-invasive and invasive pressure ventilator designed to provide bi-level positive airway pressure (BiPAP) therapy. It delivers timed and spontaneous breaths to patients with chronic respiratory insufficiency, adjusting pressure support based on the patient’s inspiratory effort. The device incorporates features such as Auto-Trak and AVAPS to optimize ventilation and improve patient comfort during treatment.
This system is supplied as a reusable medical device and is intended for use in clinical settings, including hospitals and home care environments. It operates with a maximum pressure output of 40 cmH₂O and includes a Dry Box humidifier design to enhance therapy delivery. The BiPAP A40 holds an FDA 510(k) clearance under the Anesthesiology advisory committee, adhering to regulatory standards for ventilatory support devices. Storage and maintenance follow manufacturer guidelines to ensure proper functionality and sterility.
Frequently asked questions
What is the BiPAP A40 Ventilatory Support System used for?
The BiPAP A40 is designed to provide bi-level positive airway pressure (BiPAP) therapy for patients with chronic respiratory insufficiency. It delivers timed and spontaneous breaths, adjusting pressure support based on the patient’s inspiratory effort to optimize ventilation and improve comfort. This makes it suitable for both invasive and non-invasive ventilation in clinical settings like hospitals and home care.
Is the BiPAP A40 a reusable or single-use device?
The BiPAP A40 is a reusable medical device, intended for use in clinical environments. Reusability allows for cost-effective deployment in hospitals and home care settings, provided it is maintained and stored according to manufacturer guidelines to ensure proper functionality and sterility.
What are the key features of the BiPAP A40’s humidification system?
The BiPAP A40 includes a Dry Box humidifier design, which enhances therapy delivery by improving moisture levels during ventilation. This feature helps maintain airway hydration, reducing discomfort and improving patient compliance during treatment.
What is the maximum pressure output of the BiPAP A40?
The BiPAP A40 has a maximum pressure output of 40 cmH₂O, which provides sufficient ventilatory support for patients requiring bi-level pressure therapy. This range ensures flexibility for varying patient needs while maintaining safety and efficacy.
How should the BiPAP A40 be stored and maintained?
Proper storage and maintenance of the BiPAP A40 are critical to ensure functionality and sterility. The manufacturer provides specific guidelines for cleaning, calibration, and storage to prevent contamination and equipment degradation. Adhering to these protocols extends the device’s lifespan and ensures reliable performance for patient care.
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: PHILIPS RESPIRONICS BIPAP A40 SETUP MANUAL Pdf Download, PDF Tailored ventilation - Philips, PDF BiPAP A40 USER MANUAL - HME Home Health
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K121623 | Class II | Active |
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Manufacturer
- Manufacturer
- Respironics, Inc.
Sources (1)
- FDA 510(k) K121623 24 fields · synced Oct 1, 2026