Respirator Disconnect Alarm CR201
by Intersect Medical Products, Inc.
510(k) K791527
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK791527 | Date19 Sep 1979 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- CAP
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.2600
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Respirator Disconnect Alarm CR201 is a medical device classified as a Monitor, Airway Pressure (Includes Gauge and/or Alarm). It is designed to detect disconnections in respirator circuits, providing an audible and visual alarm to alert clinicians of potential breathing circuit disruptions during patient ventilation. This device operates within the scope of airway pressure monitoring systems, ensuring patient safety by promptly signaling disconnection events in mechanical ventilation setups.
The Respirator Disconnect Alarm CR201 is intended for use in clinical settings, such as operating rooms and intensive care units, where mechanical ventilation is administered. It is a reusable device, supplied sterile or non-sterile depending on the clinical protocol, and adheres to regulatory standards outlined in 21 CFR 868.2600. The device is classified as Class II under FDA regulations and has received a Traditional 510(k) clearance through the Anesthesiology Advisory Committee. It is not MRI-safe and must be stored according to manufacturer guidelines to maintain functionality.
Other devices from Intersect Medical Products, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Respirator Disconnect Alarm CR201 used for?
The Respirator Disconnect Alarm CR201 is designed to detect disconnections in respirator circuits during mechanical ventilation. It provides immediate audible and visual alarms to alert clinicians of potential breathing circuit disruptions, helping maintain patient safety in settings like operating rooms and intensive care units.
Is the Respirator Disconnect Alarm CR201 a single-use or reusable device?
The Respirator Disconnect Alarm CR201 is a reusable device. Its sterility depends on clinical protocols, as it can be supplied either sterile or non-sterile based on the intended use and facility requirements.
What regulatory standards does the Respirator Disconnect Alarm CR201 comply with?
The Respirator Disconnect Alarm CR201 adheres to regulatory standards outlined in 21 CFR 868.2600. It is classified as a Class II device under FDA regulations and has received Traditional 510(k) clearance through the Anesthesiology Advisory Committee.
Can the Respirator Disconnect Alarm CR201 be used in MRI environments?
No, the Respirator Disconnect Alarm CR201 is not MRI-safe. It must not be used in magnetic resonance imaging environments, as this could compromise its functionality or pose risks to the device or patient.
How should the Respirator Disconnect Alarm CR201 be stored?
The Respirator Disconnect Alarm CR201 must be stored according to the manufacturer’s guidelines to maintain its functionality. Proper storage conditions ensure reliability and longevity, particularly if the device is reused in clinical settings.