CNAP Monitor 500I, 500AT
510(k) K082599
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK082599 | Date17 Oct 2008 | 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- Withdrawn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
- Full name
- Non-Invasive Continuous Blood Pressure Monitoring System Cnap Monitor 500I, 500AT
- 510(k) Number
- FDA Product Code
- DXN
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1130
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The CNAP Monitor 500I, 500AT is a non-invasive continuous blood pressure monitoring system designed for real-time assessment of blood pressure waveforms and hemodynamic parameters. It provides beat-to-beat systolic, diastolic, and mean arterial pressure measurements, as well as pulse rate, without requiring invasive procedures.
This device is intended for use in hospital settings, offering continuous monitoring for perioperative fluid management in low- and moderate-risk surgeries. Supplied as a reusable system, it adheres to FDA 510(k) clearance under the traditional review pathway (K082599, SESE) and is manufactured by Cnsystem Medizintechnik AG in Graz, Austria. No specific sterility or MRI safety information is provided in the available data.
Questions
AI-generated answers, 19 Sep 2026
Is the CNAP Monitor 500I/500AT system designed for use outside of the operating room, or is it specifically for perioperative fluid management only?
The CNAP Monitor 500I, 500AT is explicitly intended for hospital settings and perioperative fluid management in low- and moderate-risk surgeries. While its primary use is during surgery, the continuous blood pressure monitoring capabilities could theoretically support critical care or recovery monitoring—though this is not explicitly stated in the device description. Always confirm intended use with your facility’s clinical guidelines.
How is the CNAP Monitor 500I/500AT system supplied, and can it be reused across multiple patients?
The system is supplied as a reusable device, meaning it is not single-use. However, reuse requires adherence to your facility’s infection control protocols, as no sterility information is provided in the available data. The manufacturer, Cnsystem Medizintechnik AG, is responsible for maintenance and cleaning instructions, which should be followed strictly to ensure accurate and safe operation.
What types of blood pressure measurements does the CNAP Monitor 500I/500AT provide, and how does it differ from traditional cuff-based monitors?
Unlike traditional intermittent cuff-based monitors, the CNAP Monitor 500I/500AT offers continuous, beat-to-beat measurements of systolic, diastolic, and mean arterial pressure, along with pulse rate. This provides real-time hemodynamic assessment without invasive procedures, making it useful for dynamic perioperative monitoring where fluctuations in blood pressure need immediate attention.
What regulatory pathway was followed for FDA clearance of the CNAP Monitor 500I/500AT, and which advisory committee was involved?
The device received FDA clearance under the traditional review pathway (510(k)) with a Substantially Equivalent (SESE) determination. The review was conducted by the Cardiovascular (CV) Advisory Committee, and the clearance was granted on October 17, 2008, under the product code DXN. This pathway ensures the device meets FDA standards for non-invasive blood pressure monitoring.