# K030613: Vital Signs Monitor W/Arrhythmia Detection and ST Analysis, Model 8100

- Pathway: 510(k) (Special)
- Applicant: Criticare Systems, Inc.
- Decided: Apr 17, 2003 after 50 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K942737 (1995). 3 ancestors in all.
1 later device descends 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)
- K012059: 8100/8500 Vital Signs Monitor, Criticare Systems, Inc. (2001)

## Most influential descendants
- K101602: Vital Signs Monitor (2010), 0 descendants of its own

## Recalls of this device
- May 6, 2026 · Class II · Z-3253-2026: Complaint trend where "Checkline Error" alarm presents at device setup, rendering the CO2 monitoring function inoperable. May result in procedure delay.

## 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.

Source page: https://510kreport.com/device/K030613
Methodology: https://510kreport.com/methodology