# K091787: Model 6000 Two Parameter Bedside Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Ivy Biomedical Systems, Inc.
- Decided: Oct 9, 2009 after 114 days
- Product code: DQA (Oximeter)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K962603 (1997). 35 ancestors in all.
No later device cites it as a predicate yet.
1 of 36 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060065: CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter Bedside Monitor, Oridion Capnography, Inc. (2006) Summary page 1.

## Indications for use
The Model 6000 is intended to provide continuous noninvasive monitoring of SpO 2 and EtCO 2 indications. The parameters are derived from both the measurements of arterial oxygen hemoglobin saturation and pulse rates as well as relative expired and inspired CO 2 levels. The recorded data may be displayed locally and also transmitted wirelessly to any device supporting the 802.11 communication protocol This device is intended for use on adult, geriatric, pediatric, and neonatal patients in bedside or mobile applications within health care institutions and/or health care environments only under the direction of a physician or qualified clinician.

Source page: https://510kreport.com/device/K091787
Methodology: https://510kreport.com/methodology