Portable Sleep Data Recorder (PSDR)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K033402 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 Portable Sleep Data Recorder (PSDR) is a Ventilatory Effort Recorder, designed to monitor physiological signals during sleep studies. It records thoracic and abdominal respiratory effort, oxygen saturation (SpO₂), pulse rate, and auxiliary 0-1V DC inputs such as CPAP pressure, enabling comprehensive assessment of ventilatory patterns and respiratory events.
The PSDR is intended for use in hospital, institutional, or home environments to capture real-time data for later playback and clinical review. Supplied as a reusable device under 21 CFR 868.2375, it has received FDA 510(k) clearance (K033402) and is classified as a Class II medical device. No specific sterility or MRI safety information is provided in the regulatory data.
Frequently asked questions
What types of physiological signals does the Portable Sleep Data Recorder (PSDR) monitor during sleep studies, and how might this benefit clinical assessment?
The PSDR records thoracic and abdominal respiratory effort, oxygen saturation (SpO₂), pulse rate, and auxiliary 0-1V DC inputs such as CPAP pressure. This comprehensive data capture enables clinicians to assess ventilatory patterns, detect respiratory events (e.g., apneas or hypopneas), and evaluate the effectiveness of treatments like CPAP therapy in real-time or during later review. The inclusion of auxiliary inputs also allows for correlation with external devices, improving diagnostic accuracy.
Is the PSDR designed for single-use or reusable applications, and what does this mean for maintenance and cost considerations?
The PSDR is explicitly classified as a reusable device under 21 CFR 868.2375, meaning it is intended for repeated use across multiple patients after proper cleaning, disinfection, and maintenance. This design reduces per-patient costs but requires adherence to facility protocols for reprocessing to ensure safety and functionality. Clinicians should confirm their institution’s policies for cleaning and sterilization, though no specific sterility claims are provided in the regulatory data.
Where can the PSDR be used, and what environments are suitable for deployment?
The PSDR is approved for use in hospital, institutional, or home environments, making it versatile for both clinical and patient-centered applications. Its portability allows for flexible deployment in sleep labs, intensive care units, or even patient homes for long-term monitoring. The device’s design prioritizes ease of use in these settings, though specific environmental constraints (e.g., temperature, humidity) are not detailed in the provided data.
How do I determine which model or variant of the PSDR is right for my facility, given the multiple registration numbers listed?
The registration numbers (e.g., 3013689228, 3002806730) correspond to different product codes (MNR) and FEI numbers, which may reflect variations in software versions, firmware updates, or minor hardware revisions rather than distinct clinical indications. Pro-Tech Services, Inc. likely maintains a list of compatible models for your facility’s specific needs. Contacting their technical support or reviewing their latest documentation will clarify which variant aligns with your workflow, as the data does not specify functional differences between these registrations.
Does the PSDR require any special handling or storage conditions to maintain its performance and data integrity?
While the regulatory data does not provide explicit storage guidelines, reusable medical devices like the PSDR typically require protection from physical damage, extreme temperatures, and moisture to preserve functionality. Facilities should follow standard protocols for storing electronic medical devices, such as keeping them in a dry, temperature-controlled environment and avoiding exposure to electromagnetic interference. Always refer to the manufacturer’s instructions for device-specific care, as these details may not be reflected in the submitted regulatory documentation.
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: PORTABLE SLEEP DATA RECORDER (PSDR) - Innolitics, PORTABLE SLEEP DATA RECORDER (PSDR) 510(k) K033402 - FDA.report, PDF Public Health Service Food and Drug Administration JUN 3 0 2904, Pro-Tech Services, Inc. FDA 510 (k) Products (1994-2005)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K033402 | Class II | Active |
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Manufacturer
- Manufacturer
- Pro-Tech Services, Inc.
Sources (1)
- FDA 510(k) K033402 24 fields · synced Sep 19, 2026