# K160582: WiCap

- Pathway: 510(k) (Abbreviated)
- Applicant: Athena Gtx
- Decided: Sep 2, 2016 after 185 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 4.

## Indications for use
The WiCap™ patient monitor is intended for the continuous or spot-check monitoring of carbon dioxide concentration of the expired (EtCO2) and inspired (FiCO2) breath and respiration rate (RR), and functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) measurements. Intended patient populations include: Adult, Pediatric, and Neonate patients. The device is for use in hospitals, healthcare facilities and clinics, nursing home facilities, and other healthcare environments. The WiCap™ patient monitor is to be used by trained healthcare providers.

Source page: https://510kreport.com/device/K160582
Methodology: https://510kreport.com/methodology