# K093017: Stellar 300

- Pathway: 510(k) (Traditional)
- Applicant: Larsen & Toubro Limited
- Decided: Apr 29, 2010 after 212 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: 4 generations back to K952474 (1995). 5 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060058: Stellar 404T, Larsen & Toubro Limited (2006) Summary page 2.

## Most influential descendants
- K103686: STAR 50 N (2011), 1 descendant of its own
- K132033: BM3/BM3 Plus (2013), 0 descendants of its own

## Indications for use
The STELLAR 300 - three parameter Patient Monitoring system is intended to monitor a single Adult or Pediatric patient's vital signs at the bedside or during intra-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) and Temperature 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/K093017
Methodology: https://510kreport.com/methodology