# K083821: Vital Signs Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Edan Instruments, Inc.
- Decided: May 14, 2009 after 143 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). 39 ancestors in all.
39 later devices descend from it; 5 cite it directly.
1 of 79 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.
- K032971: Tidal Wave SP Model 710/715                                       and 715, Respironics Novametrix, Inc. (2004) Summary page 1.

## Most influential descendants
- K093016: Vital Signs Monitor (2010), 16 descendants of its own
- K113623: Patient Monitor (2012), 15 descendants of its own
- K131971: IM60/IM70 Patient Monitor (2014), 14 descendants of its own
- K123711: Patient Monitor (2013), 13 descendants of its own
- K120173: Patient Monitor (2012), 10 descendants of its own

## Indications for use
The Vital Signs Monitor is indicated for use for non-invasive continuous monitoring of oxygen saturation of the blood (SpO2) and C02. The Vital Signs Monitor is intended to be used only under regular supervision of clinical personnel. It is adaptable to adult, pediatric, and neonatal usage in a hospital environment and intra-hospital moves. The Vital Signs Monitor is equipped with alarms that indicate system faults (such as loose or defective electrodes), physiologic parameters that have exceeded the limits set by the operator, or both.

Source page: https://510kreport.com/device/K083821
Methodology: https://510kreport.com/methodology