# K001020: 8100 Vital Signs Monitor

- Pathway: 510(k) (Special)
- Applicant: Criticare Systems, Inc.
- Decided: Apr 28, 2000 after 29 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
No predicates in its family tree.
270 later devices descend from it; 5 cite it directly.
1 of 271 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K032867: Star (Lunar Series) Monitoring System (2003), 260 descendants of its own
- K051608: Star 50 Monitoring System (2005), 259 descendants of its own
- K060065: CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter Bedside Monitor (2006), 250 descendants of its own
- K072295: Capnostream 20 with A2 Adaptive Averaging Software (2007), 197 descendants of its own
- K082268: CAPNOSTREAM20 with Integrated Pulmonary Index (2009), 170 descendants of its own

Source page: https://510kreport.com/device/K001020
Methodology: https://510kreport.com/methodology