Stellar 404 Monitoring System
510(k) K042560
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK042560 | Date6 Oct 2004 | 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- Withdrawn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
- MWI
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.2300
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Stellar 404 Monitoring System is a bedside or intra-hospital transport patient monitor designed to continuously assess vital signs in adult, pediatric, and neonatal patients. It incorporates a plethysmograph for pulse oximetry (SpO₂) and non-invasive blood pressure monitoring, alongside derived parameters such as pulse rate (PR). The device provides real-time digital readouts and visual displays of these measurements, enabling clinical observation during patient care or movement within a healthcare facility.
The system is supplied as a reusable medical device and is intended for use in hospital settings, including intensive care units, emergency departments, and transport scenarios. It requires appropriate accessories (e.g., leads, sensors) for operation and must be maintained according to manufacturer guidelines. The device holds FDA 510(k) clearance under the Cardiovascular (CV) advisory committee and is classified under product code MWI. Sterility and MRI safety specifications are not detailed in the available data.
Other devices from Larsen & Toubro Limited
Questions
AI-generated answers, 1 Oct 2026
What types of patients is the Stellar 404 Monitoring System designed for?
The Stellar 404 Monitoring System is specifically designed for continuous vital sign monitoring in adult, pediatric, and neonatal patients. Its versatility makes it suitable for use in diverse clinical settings, including intensive care units, emergency departments, and during intra-hospital transport, ensuring accurate and real-time assessment of critical parameters like SpO₂, blood pressure, and pulse rate.
Is the Stellar 404 Monitoring System reusable or single-use?
The Stellar 404 Monitoring System is a reusable medical device. It is intended for repeated use within hospital environments, provided it is maintained and serviced according to the manufacturer’s guidelines to ensure reliability and accuracy over time.
What accessories are required to operate the Stellar 404 Monitoring System?
To operate the Stellar 404 Monitoring System, appropriate accessories such as leads and sensors are necessary. These components are essential for attaching to the patient and enabling the device to measure vital signs like pulse oximetry and blood pressure. The manufacturer provides specific instructions on compatibility and usage.
Where can the Stellar 404 Monitoring System be used?
The Stellar 404 Monitoring System is intended for use in hospital settings, including intensive care units, emergency departments, and during intra-hospital transport. Its design allows for continuous monitoring of patients while they are being moved or cared for within these environments, ensuring clinical observation remains possible.
Does the Stellar 404 Monitoring System include any sterility specifications?
The available data does not provide explicit details regarding sterility specifications for the Stellar 404 Monitoring System. However, as a reusable device, it must be cleaned and maintained according to manufacturer guidelines to prevent contamination and ensure safe clinical use.