Vital Signs Monitor, Propaq LT
FDA 510(k) K033378 · Welch Allyn Protocol, Inc.
510(k) numberK033378
Submission
- Device name
- Vital Signs Monitor, Propaq LT
- Applicant
- Welch Allyn Protocol, Inc.
Beaverton, OR, US - Received
- October 22, 2003
- Decision date
- March 1, 2004
- 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 |
|---|---|---|
| K070204 | Link to Acuity Clinician NotifierMSX · Special | 03/23/2007SE |
| K063419 | Modification to Vsm- Vital Signs Monitor, (VSM 300 )MWI · Special | 12/04/2006SE |
| K031740 | VSM - Vital Signs Monitor, Model 53000 SeriesDQA · Traditional | 08/26/2003SE |
| K022453 | Modification to Acuity Central Monitoring SystemDSI · Special | 08/21/2002SE |
| K021681 | Micropaq, Models 402, 404DRT · Special | 07/23/2002SE |
| K012451 | Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246DRT · Special | 08/20/2001SE |
Questions and answers
When was Vital Signs Monitor, Propaq LT cleared by the FDA?
Vital Signs Monitor, Propaq LT (K033378) received a 510(k) decision of Substantially Equivalent on March 1, 2004, 131 days after the submission was received.
What is the product code of K033378?
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.