# K043370: Planet 50 Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Larsen & Toubro Limited
- Decided: Feb 15, 2005 after 69 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: 1 generation back to K952474 (1995). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K952474: Eagle 3000 Patient Monitor, Marquette Electronics, Inc. (1995) Summary page 2.
- K001020: 8100 Vital Signs Monitor, Criticare Systems, Inc. (2000) Summary page 2.

## Most influential descendants
- K071472: Planet 55 (2007), 1 descendant of its own
- K090443: Planet 55, Model 100 (2009), 0 descendants of its own

## Indications for use
The PLANET 50 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), Plethysmograph Respiration and Capnography (CO2). It can also display the digital values of HR/PR, SpO2, non-invasive blood pressure (systolic, diastolic and mean) Temperature, EtCO2 and FiCO2 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/K043370
Methodology: https://510kreport.com/methodology