BiPAP Harmony S/T, Model 1001445
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K984407 FDA 510(k)
- FDA Product Code
- MNS 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 Harmony S/T, Model 1001445 is a non-invasive, electromechanical ventilator designed to deliver bi-level positive airway pressure (BiPAP) for respiratory support. It operates in Spontaneous/Timed (S/T) mode, providing adjustable inspiratory positive airway pressure (IPAP) and expiratory positive airway pressure (EPAP) to assist patient breathing.
This device is intended for home and institutional use and is classified as a Ventilator, Continuous, Non-Life-Supporting (product code MNS), under FDA 510(k) clearance (K984407). It features clinician-adjustable parameters, including rate and inspiratory time, and incorporates Auto-Trak Sensitivity for spontaneous triggering. Supplied as a reusable medical device, it adheres to regulatory standards outlined in 21 CFR 868.5895.
Frequently asked questions
What is the BiPAP Harmony S/T, Model 1001445 primarily used for in clinical settings?
The BiPAP Harmony S/T, Model 1001445 is designed as a non-invasive, electromechanical ventilator to deliver bi-level positive airway pressure (BiPAP) in Spontaneous/Timed (S/T) mode. It provides adjustable inspiratory (IPAP) and expiratory (EPAP) pressures to assist patients with respiratory support, suitable for both home and institutional use. The device is classified under FDA product code MNS (Ventilator, Continuous, Non-Life-Supporting) and is intended for patients requiring respiratory assistance.
Is the BiPAP Harmony S/T, Model 1001445 a single-use or reusable device, and how should it be handled?
The BiPAP Harmony S/T, Model 1001445 is explicitly supplied as a reusable medical device. Since it is intended for repeated use, proper cleaning, disinfection, and maintenance procedures must be followed as outlined in the manufacturer’s instructions to ensure safety and functionality. The device adheres to regulatory standards under 21 CFR 868.5895, which governs its reuse requirements.
What regulatory pathway was followed for FDA clearance of this device, and what does that mean for buyers?
The BiPAP Harmony S/T, Model 1001445 received FDA clearance through an Abbreviated 510(k) pathway (K984407), with a decision labeled as *Substantially Equivalent (SESE)*. This means the manufacturer demonstrated that the device is as safe and effective as a legally marketed predicate device, rather than requiring full pre-market approval. Buyers can rely on this clearance to indicate that the device meets FDA standards for ventilators under product code MNS (Continuous, Non-Life-Supporting).
Does this device include any automatic triggering features, and how might that benefit patients?
Yes, the BiPAP Harmony S/T incorporates Auto-Trak Sensitivity, a clinician-adjustable feature designed to enhance spontaneous triggering. This means the device can better detect and respond to a patient’s natural breathing efforts, improving comfort and synchronization between the patient’s respiratory cycle and the ventilator’s support. This is particularly useful for patients who rely on spontaneous breathing assistance.
What types of environments is this device intended for, and does it require specialized storage?
The BiPAP Harmony S/T, Model 1001445 is explicitly designed for both home and institutional use, meaning it can be deployed in hospitals, clinics, or patient homes. While the device itself does not specify unique storage requirements beyond standard medical equipment protocols, its reusable nature necessitates adherence to manufacturer guidelines for cleaning, disinfection, and storage to prevent contamination and ensure longevity. Always refer to the included instructions for proper handling.
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: BIPAP HARMONY S/T, MODEL 1001445 - fda.innolitics.com, BIPAP HARMONY S/T, MODEL 1001445 (K984407) - FDA 510 (k), RESPIRONICS BIPAP HARMONY S/T PATIENT MANUAL Pdf Download
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K984407 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Respironics, Inc.
Sources (1)
- FDA 510(k) K984407 24 fields · synced Sep 19, 2026