# K101602: Vital Signs Monitor

- Pathway: 510(k) (Special)
- Applicant: Criticare Systems, Inc.
- Decided: Sep 1, 2010 after 85 days
- Product code: MLD (Monitor, St Segment With Alarm)
- 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: 4 generations back to K944860 (1995). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012059: 8100/8500 Vital Signs Monitor, Criticare Systems, Inc. (2001) Summary page 1.
- K030613: Vital Signs Monitor W/Arrhythmia Detection and ST Analysis, Model 8100, Criticare Systems, Inc. (2003)
- K091050: 506CN Patient Monitor, Criticare Systems, Inc. (2009) Summary page 1.

## Indications for use
This system is intended to monitor physiological parameters of patients within any healthcare environment. The user, responsible to interpret the monitored data made available, will be a professional health care provider. Physiological data, system alarms and patient data analysis will be available to the care provider from the monitor. The monitored parameters are: 1. ECG 2. Noninvasive Blood Pressure (NIBP) 3. Invasive Blood Pressure (IBP) 4. Temperature 5. Respiratory Gases 6. Anesthetic Agent Gases 7. Respiratory Rate 8. Pulse Oximetry (SpO2) 9. Arrhythmia and ST Analysis of the ECG waveforms

Source page: https://510kreport.com/device/K101602
Methodology: https://510kreport.com/methodology