# K093016: Vital Signs Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Creative Industry Co., Ltd.
- Decided: Mar 30, 2010 after 182 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: 10 generations back to K962603 (1997). 40 ancestors in all.
16 later devices descend from it; 2 cite it directly.
1 of 57 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.
- K083821: Vital Signs Monitor, Edan Instruments, Inc. (2009) Summary page 1.

## Most influential descendants
- K123711: Patient Monitor (2013), 13 descendants of its own
- K170047: All-in-One Health Monitor, PC-303 (2017), 6 descendants of its own
- K210086: Vitals360 Multi-Vitals Mobile Monitor (2021), 4 descendants of its own
- K172792: Handheld Pulse Oximeter, Model SP-20 (2018), 3 descendants of its own
- K201468: Pulse Oximeter (2021), 2 descendants of its own

## Indications for use
The Vital Signs Monitor is designed for monitoring the vital physiological signs of the patient. It is used for non-invasive continuous monitoring of oxygen saturation (SP02), pulse rate, C02 and respiration rate. The Vital Signs Monitor is adaptable to adult and pediatric usage in a hospital, environment. It is intended to be used only under regular supervision of clinical personnel.

Source page: https://510kreport.com/device/K093016
Methodology: https://510kreport.com/methodology