510(k) · Cleared
ClearedZoll Propaq M
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zoll Medical Corporation, World Wide Headquarters · DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Cleared on Sep 15, 2010 after a 44-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Sep 15, 2010
- Review
- 44 days
- Class
- Class II
- Product code
- DRT
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DRT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DRT device
- #1 K252676 The Circadia C300 System (C300)score 15.3 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All DRT devicesDRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm): FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · DRT
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DRT
228in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DRT
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DRT
40in 2025
MAUDE reports naming product code DRT, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 113 |
| 2008 | 1 | — | 0 | 99 |
| 2009 | 6 | 70 | 0 | 118 |
| 2010 | 3 | 44 | 0 | 63 |
| 2011 | 3 | 149 | 1 | 36 |
| 2012 | 1 | — | 0 | 47 |
| 2013 | 1 | — | 0 | 16 |
| 2014 | 0 | — | 0 | 26 |
| 2015 | 1 | — | 0 | 48 |
| 2016 | 1 | — | 0 | 55 |
| 2017 | 1 | — | 0 | 159 |
| 2018 | 1 | — | 0 | 224 |
| 2019 | 1 | — | 0 | 447 |
| 2020 | 0 | — | 0 | 50 |
| 2021 | 2 | — | 1 | 85 |
| 2022 | 1 | — | 0 | 35 |
| 2023 | 1 | — | 0 | 47 |
| 2024 | 3 | 228 | 1 | 29 |
| 2025 | 1 | — | 0 | 40 |
| 2026 | 5 | 120 | 0 | — |
What is it indicated for?
The Propaq M is intended for use by trained medical personnel who are familiar with basic monitoring, vital sign assessment, and the use of the Propaq M. The Propaq M is also intended for use by (or on the order of) physicians at the scene of an emergency or in a hospital emergency room, intensive care unit; cardiac care unit, or other similar areas of a hospital. The usage may be in an ambulance or at the scene of an emergency. It is also intended to be…
Read the full statement (300 words)
The Propaq M is intended for use by trained medical personnel who are familiar with basic monitoring, vital sign assessment, and the use of the Propaq M. The Propaq M is also intended for use by (or on the order of) physicians at the scene of an emergency or in a hospital emergency room, intensive care unit; cardiac care unit, or other similar areas of a hospital. The usage may be in an ambulance or at the scene of an emergency. It is also intended to be used during the transport of patients. The Propaq M will be used whenever it is required to monitor any of those functions that are included (as options) in the device. The Propaq M unit can be used on pediatric patients (as described in the following table) and on adult patients (21 years of age or older) with and without heart dysfunction.
Pediatric Patient Subpopulation — Approximate Age Range
Newborn (neonate) — Birth to 1 month of age.
Infant — 1 month to 2 years of age.
Child — 2 to 12 years of age.
Adolescent — 12 to 21 years of age.
ECG Monitoring
The Propaq M is intended for use to monitor and/or record 3-, 5-, or 12-lead ECG waveform and heart rate, and to alarm when heart rate is above or below limits set by the operator. The patient population will range from newborn (neonate) to adult, with and without heart dysfunction.
Non-Invasive Blood Pressure Monitoring
The Propaq M is intended for use to make non-invasive measurements of arterial pressure and heart rate, and to alarm if either parameter is outside of the limits set by the user. Measurements are made using an inflatable cuff on the patient's arm or leg. The patient population will range from newborn (neonate) to adult.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K102174 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102174: Zoll Propaq M.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102174
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026