# K042569: 8600 Vital Signs Monitor

- Pathway: 510(k) (Special)
- Applicant: Criticare Systems, Inc.
- Decided: Sep 29, 2004 after 8 days
- Product code: MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: 3 (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.
No later device cites it as a predicate yet.
0 of 4 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.

## Recalls of this device
- Nov 21, 2013 · Class II · Z-0810-2014: The main board, P/N 301641, installed in some Medrad Veris MR Monitor units may be faulty and could lead to unexpected shutdown of the system while in use, resulting in the loss of vital signs informa
- Apr 15, 2013 · Class II · Z-1586-2013: The firm is recalling these power cables due to a latent design reliability issue and the potential for shorting which can result in heating/melting of the cable jacket.
- Sep 29, 2006 · Not classified · Z-0259-2007: Interference problems: certain invasive blood pressure transducers connected to these cables are susceptible to interference if exposed to static magnetic field strengths exceeding 300 gauss. In certa

## 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/K042569
Methodology: https://510kreport.com/methodology