# K090172: Star 55 Model 100

- Pathway: 510(k) (Traditional)
- Applicant: Larsen & Toubro Limited
- Decided: Jun 5, 2009 after 133 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K941811 (1994). 81 ancestors in all.
No later device cites it as a predicate yet.
0 of 82 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080173: STAR 55, Larsen & Toubro Limited (2008) Summary page 2.

## Cited in the summary but kept off the family tree
- K020330: Deployable Oxygen Concentration System (Docs), Pacific Consolidated Industries Llp (2002). Our OCR of the scanned summary read K020330, FDA’s number for Deployable Oxygen Concentration System (Docs) (Pacific Consolidated Industries Llp). Its FDA name has none of the distinctive words the summary uses for the device it names, “Passport 2 Vital signs monitor with View 12 ECG Analysis Module”. Kept off the family tree.

## Indications for use
The STAR 55 Model 100 multi-parameter Patient Monitoring system is intended to monitor a single Adult, Pediatric or Neonatal patient's vital signs at the bedside or during intra-hospital transport along with the appropriate accessories mentioned / supplied with the unit. Vital signs parameters include ECG (3 lead /5 lead/ 12 lead), SpO2, Respiration, Temperature, Capnography (CO 2) & optional Gas module unit. It can also display the digital values of HR/PR, SPO2, RR, Non-Invasive Blood Pressure (Systolic, Diastolic and Mean),' Invasive Blood Pressure (Systolic, Diastolic and Mean), Temperature, EtCO2, FiCO2 , N 2 0, 02, EtAA and FiAA readings. In addition, Star 55 Model 100 has got Arrhythmia and ST detection from 3L/5L/12L ECG measurements. The Arrhythmia and ST analysis module is intended for use with Adult & Pediatric patients and is not intended for use with Neonatal patients The user, responsible to interpret the monitored data made available, will be a professional health care provider. The 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/K090172
Methodology: https://510kreport.com/methodology