WVSM Pro (Series) (500-0030-XX)
FDA 510(k) K233354 · Athena Gtx, Inc.
510(k) numberK233354
Submission
- Device name
- WVSM Pro (Series) (500-0030-XX)
- Applicant
- Athena Gtx, Inc.
Johnson, IA, US - Received
- September 29, 2023
- Decision date
- June 26, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MWI – Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2300
- Specialty
- Cardiovascular
Other 510(k)s with product code MWI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260438 | Vital Signs Monitor (CLEO2)MWI · Traditional | Infinium Medical, Inc. | 08/14/2026SE |
| K253417 | Masimo Root Monitoring SystemMWI · Traditional | Masimo Corporation | 08/12/2026SE |
| K253196 | Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)MWI · Traditional | Midmark Corporation | 06/12/2026SE |
| K253436 | c-med0 alphaMWI · Traditional | Cosinuss GmbH | 04/30/2026SE |
| K250135 | WAVE Clinical Platform (2.0.000)MWI · Traditional | Baxter Healthcare Corp/ Excel Medical | 01/16/2026SE |
| K241766 | QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)MWI · Traditional | Fysicon BV | 08/27/2025SE |
| K242737 | Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalMWI · Traditional | Empatica S.r.l. | 06/06/2025SE |
| K241958 | WARD-CSS (v1.2.x)MWI · Traditional | Ward 24/7 Aps | 02/14/2025SE |
| K243146 | iCare APPMWI · Traditional | Ihealth Labs, Inc. | 02/03/2025SE |
| K241411 | Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM)MWI · Traditional | Welch Allyn, Inc. | 12/20/2024SE |
More from Welch Allyn, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K191989 | WVSM (Wireless Vital Signs Monitor) RWC + miniCapMWI · Traditional | 01/29/2020SE |
| K173203 | Athena GTX Device Management Suite (ADMS) SoftwareMSX · Traditional | 03/14/2018SE |
| K160582 | WiCapDQA · Abbreviated | 09/02/2016SE |
| K153459 | TacvacBTA · Abbreviated | 01/28/2016SE |
| K130957 | WVSM (Wirless Vital Signs Monitor)MWI · Special | 04/30/2013SE |
| K113165 | Mini-MedicMWI · Traditional | 02/02/2012SE |
| K101674 | WVSM (Wireless Vital Signs Monitor), Model 5.0MWI · Traditional | 07/21/2010SE |
Questions and answers
When was WVSM Pro (Series) (500-0030-XX) cleared by the FDA?
WVSM Pro (Series) (500-0030-XX) (K233354) received a 510(k) decision of Substantially Equivalent on June 26, 2024, 271 days after the submission was received.
What is the product code of K233354?
The FDA product code is MWI – Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms), a Class II (moderate risk) device regulated under 21 CFR 870.2300.