Stardust Ventilatory Effort Recorder
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K973920 FDA 510(k)
- FDA Product Code
- MNR FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.2375 FDA 510(k)
- Regulation Number
- 868.2375 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Stardust Ventilatory Effort Recorder is a medical device classified as a ventilatory effort recorder, designed to monitor and record respiratory effort during mechanical ventilation. It is intended for use in clinical settings where patient ventilatory effort must be assessed, such as in intensive care or perioperative environments. The device provides diagnostic data to evaluate patient-ventilator synchrony and respiratory muscle activity, aiding in the management of ventilated patients.
The Stardust is supplied as a reusable device, intended for use in hospital or clinical environments. It operates in non-sterile conditions and is not classified as MRI-safe. The device is authorized under FDA 510(k) clearance (K973920) and falls under the medical specialty of anesthesiology. It is regulated under the FDA’s regulation number 868.2375 and is designed for single-patient use per session, with no specified storage requirements beyond standard medical device protocols.
Frequently asked questions
What clinical environments is the Stardust Ventilatory Effort Recorder intended for use in?
The Stardust is designed for clinical settings where assessing patient ventilatory effort is critical, such as intensive care units (ICUs) or perioperative environments. It helps evaluate patient-ventilator synchrony and respiratory muscle activity, supporting the management of ventilated patients in these high-acuity areas.
Is the Stardust Ventilatory Effort Recorder reusable or single-use, and how should it be handled between sessions?
The Stardust is explicitly labeled as a reusable device, intended for use in hospital or clinical environments. Since it operates in non-sterile conditions, it should be cleaned and maintained according to standard medical device protocols between sessions. No specific storage requirements beyond typical medical device guidelines are mentioned.
What regulatory pathway was followed for FDA clearance of the Stardust Ventilatory Effort Recorder?
The Stardust received FDA clearance through a 510(k) pathway, specifically under the traditional review process (K-number: K973920). It was determined to be substantially equivalent to a predicate device and falls under the Anesthesiology specialty, regulated under FDA’s 868.2375 classification for ventilatory effort recorders.
Does the Stardust come in multiple sizes or models, and if so, how are they differentiated?
The Stardust is associated with multiple FEI numbers (e.g., 3013689228, 3002806730, etc.), which may correspond to different models or configurations. However, the provided data does not specify how these are differentiated (e.g., by features, software versions, or hardware variants). For precise sizing or model details, refer to the manufacturer’s documentation or catalog.
Can the Stardust be used in an MRI environment, and what are its safety considerations?
The Stardust is not classified as MRI-safe, meaning it should not be used in or near MRI machines. This is explicitly noted in the device description, so clinicians must ensure it is removed from the patient and the MRI environment before imaging procedures.
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 STARDUST II SLEEP RECORDER from Progressive Home Medical, Respironics Stardust II - Operating instructions, User's manual, Respironics Stardust II Operation Procedure - ManualsLib, Respironics STARDUST II SLEEP RECORDER from Finley Hartig Homecare
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K973920 | Class II | Active |
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Manufacturer
- Manufacturer
- Respironics, Inc.
Sources (1)
- FDA 510(k) K973920 24 fields · synced Sep 20, 2026