Watch-PAT200U Ventilatory Effort Recorder
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K161579 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 Watch-PAT200U is a ventilatory effort recorder, designed to monitor respiratory effort and sleep-related breathing patterns. It utilises patented technology to detect apnoeas, hypopnoeas, and other respiratory events by measuring changes in peripheral arterial tone and body position. This non-invasive device is primarily used in the assessment of sleep-disordered breathing, including obstructive sleep apnoea (OSA).
The Watch-PAT200U is supplied as a reusable medical device and is intended for use in clinical settings such as sleep laboratories or home monitoring environments. It operates without the need for MRI compatibility and is classified as a Class II device under FDA regulations. The device requires calibration and maintenance as specified in its operational manuals. Authorisation for this device includes an FDA 510(k) clearance under the advisory committee for Anesthesiology, with a decision date of February 24, 2017.
Frequently asked questions
What clinical environments is the Watch-PAT200U intended for, and how does its reusable design impact its use?
The Watch-PAT200U is designed for clinical settings such as sleep laboratories and home monitoring environments, where it can assess sleep-disordered breathing, including obstructive sleep apnea (OSA). Its reusable nature means it must be properly calibrated and maintained according to the manufacturer’s operational manuals, ensuring consistent performance across multiple patients. This design reduces single-use waste but requires adherence to cleaning and sterilization protocols to prevent cross-contamination between uses.
How does the Watch-PAT200U detect respiratory events, and what makes its technology non-invasive?
The Watch-PAT200U uses patented technology to measure changes in peripheral arterial tone and body position, allowing it to detect apneas, hypopneas, and other respiratory events without requiring invasive procedures like nasal or oral cannulas. This non-invasive approach makes it suitable for long-term monitoring during sleep, as it avoids discomfort or interference with natural breathing patterns.
What regulatory pathway was followed for FDA clearance of the Watch-PAT200U, and what does this mean for its use in the U.S.?
The Watch-PAT200U received FDA clearance through a 510(k) submission, classified as *Substantially Equivalent* under the Anesthesiology advisory committee (AN). This means the device was determined to be as safe and effective as a legally marketed predicate device, allowing it to be legally marketed in the U.S. for its intended use in assessing sleep-disordered breathing. The clearance date was February 24, 2017.
Does the Watch-PAT200U require any special handling or storage conditions, and is it compatible with MRI environments?
The Watch-PAT200U is not MRI-compatible, so it cannot be used or stored in MRI environments without risking interference or damage. While the device itself is reusable, its proper operation depends on calibration and maintenance as outlined in the manufacturer’s guidelines. No specific storage conditions (e.g., temperature or humidity) are mentioned in the provided data, but standard medical device storage practices should be followed to preserve functionality.
Are there multiple models or sizes available for the Watch-PAT200U, and how would a clinician determine the appropriate configuration?
The provided data lists multiple FEI numbers (e.g., 3013689228, 3002806730) associated with the Watch-PAT200U, which may correspond to different configurations, software versions, or regional adaptations. However, no explicit details about physical sizes, models, or clinical variations (e.g., pediatric vs. adult) are specified. Clinicians should consult the manufacturer’s documentation or support team to confirm compatibility with their intended patient population or monitoring needs.
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: ITAMAR MEDICAL WATCHPAT 200U OPERATION MANUAL Pdf Download, PDF Watch _PAT - itamar-medical.com, Itamar medical WatchPAT 200U Manuals | ManualsLib, PDF Watch-PAT200 - SleepWorks Medical
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K161579 | Class II | Active |
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Manufacturer
- Manufacturer
- Itamar Medical Ltd
- FDA Applicant
- Itamar Medical , Ltd.
Sources (1)
- FDA 510(k) K161579 24 fields · synced Sep 20, 2026