Identifiers
- 510(k) Number
- K160582 FDA 510(k)
- FDA Product Code
- DQA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.2700 FDA 510(k)
- Regulation Number
- 870.2700 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
WiCap is a wireless capnography device that provides instantaneous and continuous monitoring of expired carbon dioxide (EtCO₂), inspired carbon dioxide (FiCO₂), respiration rate (RR), peripheral oxygen saturation (SpO₂), and pulse rate (PR). It operates as a low‑flow, sidestream system and can be powered from a medical‑grade AC adapter or an internal rechargeable lithium‑polymer battery.
The device is classified as a Class II medical device and received FDA 510(k) clearance (abbreviated) under decision code SESE on 2016‑09‑02 (product code DQA, K‑number K160582). It is supplied by Athena GTX and is intended for cardiovascular monitoring settings. The clearance indicates substantial equivalence to a predicate device, and the device is identified by the name WiCap without any trademark symbols.
Frequently asked questions
What parameters does the WiCap monitor?
The WiCap provides instantaneous and continuous monitoring of expired carbon dioxide (EtCO₂), inspired carbon dioxide (FiCO₂), respiration rate (RR), peripheral oxygen saturation (SpO₂), and pulse rate (PR). It is designed for cardiovascular monitoring settings.
How is the WiCap powered?
The device can be powered either from a medical-grade AC adapter or via an internal rechargeable lithium-polymer battery, allowing for flexible use in clinical environments.
What type of capnography system is WiCap?
WiCap operates as a low-flow, sidestream capnography system. This design typically involves drawing a small sample of exhaled gas from the patient circuit to the analyzer, which is suitable for continuous monitoring in various care settings.
Who is the manufacturer of WiCap?
WiCap is manufactured and supplied by Athena Gtx, a company based in Johnson, Iowa, USA. The device is marketed under the name WiCap without any trademark symbols.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: WiCap 510 (k) K160582 - FDA.report, WiCap Documents - Athena GTX® Inc., PDF WiCap - Athena GTX® Inc., PDF Section 20 Clinical - Food and Drug Administration
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K160582 | Class II | Active |
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Manufacturer
- Manufacturer
- Athena Gtx
Sources (1)
- FDA 510(k) K160582 24 fields · synced Sep 28, 2026