RemStar Auto CPAP System Modification
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K031460 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)
This device is a Ventilator, Non-Continuous (Respirator) designed for continuous positive airway pressure (CPAP) therapy. It delivers a consistent airflow to maintain open airways in patients with obstructive sleep apnea, ensuring uninterrupted breathing during sleep.
The RemStar Auto CPAP System Modification is intended for use in clinical and home settings under physician supervision. It is a reusable device, not sterile, and operates without MRI compatibility restrictions. Authorized under FDA 510K clearance (K031460), it adheres to regulatory standards for ventilatory support in spontaneously breathing patients weighing over 66 lbs (30 kg).
Frequently asked questions
What clinical settings is the RemStar Auto CPAP System Modification approved for use in, and who should oversee its application?
The RemStar Auto CPAP System Modification is authorized for use in both clinical and home settings. It is designed to be used under physician supervision, ensuring appropriate patient monitoring and management of obstructive sleep apnea therapy.
Is the RemStar Auto CPAP System Modification intended for single-use or reusable applications, and what does this mean for maintenance?
The RemStar Auto CPAP System Modification is a reusable device, meaning it is not meant for single-use. Since it is not sterile, proper cleaning and maintenance protocols must be followed to ensure hygiene and functionality between uses.
What is the minimum patient weight requirement for using the RemStar Auto CPAP System Modification, and why is this specified?
The RemStar Auto CPAP System Modification is intended for use in patients weighing over 66 lbs (30 kg). This weight requirement is specified to ensure the device operates effectively and safely within its intended design parameters for spontaneously breathing patients.
How does the RemStar Auto CPAP System Modification differ from standard CPAP devices in terms of its regulatory pathway?
The RemStar Auto CPAP System Modification underwent a modification process through an FDA 510(k) clearance (K031460) with a classification as a Special type clearance under the Anesthesiology advisory committee. This indicates it was evaluated for substantial equivalence to a predicate device and adheres to regulatory standards for ventilatory support.
Are there any restrictions on using the RemStar Auto CPAP System Modification in environments with MRI equipment?
No, the RemStar Auto CPAP System Modification does not have MRI compatibility restrictions, meaning it can be used in settings where MRI machines are present without interference concerns.
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 REMSTAR AUTO USER MANUAL Pdf Download, RESPIRONICS REMSTAR USER MANUAL Pdf Download | ManualsLib, Respironics M Series REMstarPro, REMstarAuto CPAP Device ... - Manualzz, PDF |Auto with C-Flex |Pro 2 REMstar
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K031460 | Class II | Active |
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Manufacturer
- Manufacturer
- Respironics, Inc.
Sources (1)
- FDA 510(k) K031460 24 fields · synced Sep 19, 2026