# K042560: Stellar 404 Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Larsen & Toubro Limited
- Decided: Oct 6, 2004 after 15 days
- Product code: MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K952474 (1995). 3 ancestors in all.
7 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032871: Planet Monitoring System, Larsen & Toubro Limited (2003) Summary page 2.

## Most influential descendants
- K060058: Stellar 404T (2006), 6 descendants of its own
- K103763: Stellar 300 (2011), 2 descendants of its own
- K093017: Stellar 300 (2010), 2 descendants of its own
- K103686: STAR 50 N (2011), 1 descendant of its own
- K152831: Spot Skan (2016), 0 descendants of its own

## Indications for use
The STELLAR 404 two parameter Patient Monitoring System is intended to monitor a single adult, pediatric or neonatal patient's vital signs at the bedside or during hospital transport along with the appropriate accessories mentioned/ supplied with the unit. Vital signs parameter includes Plethysmograph. It can also display the digital values of PR, SPO2, Non-Invasive Blood Pressure (Systolic, Diastolic and Mean) readings. The user, responsible to interpret the monitored data made available, will be a professional health-care provider. The device, which can also be used as a portable device, permits patient monitoring with adjustable alarm limits as well as visible and audible alarm signals. The monitor is not intended for home use.

Source page: https://510kreport.com/device/K042560
Methodology: https://510kreport.com/methodology