ZOLL Propaq M
FDA 510(k) K202375 · ZOLL Medical Corporation
510(k) numberK202375
Submission
- Device name
- ZOLL Propaq M
- Applicant
- ZOLL Medical Corporation
Chelsmford, MA, US - Received
- August 20, 2020
- Decision date
- March 9, 2021
- 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 |
|---|---|---|
| K233486 | 731 Series VentilatorCBK · Traditional | 12/13/2024SE |
| K180482 | ZOLL Propaq MMHX · Traditional | 11/30/2018SE |
| K172653 | Power InfuserFRN · Traditional | 07/18/2018SE |
| K162832 | 731 Series VentilatorsCBK · Traditional | 08/02/2017SE |
| K170533 | Model 330 Multifunction AspiratorBTA · Traditional | 04/18/2017SE |
| K142915 | ZOLL X SeriesMKJ · Traditional | 12/03/2014SE |
| K141774 | Zoll X SeriesMKJ · Traditional | 11/19/2014SE |
| K140502 | Zoll E Series AlsLDD · Traditional | 11/06/2014SE |
| K133484 | Zoll X SeriesMKJ · Traditional | 08/01/2014SE |
| K132488 | Zoll Code WriterDXJ · Traditional | 04/03/2014SE |
Questions and answers
When was ZOLL Propaq M cleared by the FDA?
ZOLL Propaq M (K202375) received a 510(k) decision of Substantially Equivalent on March 9, 2021, 201 days after the submission was received.
What is the product code of K202375?
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.