510(k) · Cleared
ClearedNR Recorder
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Norav Medical GmbH · MWJ Electrocardiograph, Ambulatory (Without Analysis)
Cleared on Jun 13, 2016 after a 59-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Jun 13, 2016
- Review
- 59 days
- Class
- Class II
- Product code
- MWJ
- 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 MWJ? 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 MWJ device
- #1 K254119 Wearable ECG Recorder (YMHeart XY-12)…score 14.1 · 8 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 MWJ devicesMWJ Electrocardiograph, Ambulatory (Without Analysis): FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · MWJ
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MWJ
337in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MWJ
2in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MWJ
8in 2025
MAUDE reports naming product code MWJ, 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 | 5 | 142 | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 5 |
| 2010 | 3 | 90 | 0 | 0 |
| 2011 | 3 | 206 | 0 | 0 |
| 2012 | 1 | — | 0 | 2 |
| 2013 | 3 | 241 | 0 | 4 |
| 2014 | 2 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 2 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 4 |
| 2020 | 0 | — | 0 | 12 |
| 2021 | 1 | — | 0 | 3 |
| 2022 | 4 | 337 | 0 | 6 |
| 2023 | 0 | — | 0 | 5 |
| 2024 | 2 | — | 2 | 3 |
| 2025 | 0 | — | 0 | 8 |
| 2026 | 5 | 270 | 0 | — |
What is it indicated for?
The NR recorder is intended for patients requiring: • Ambulatory (Holter) monitoring • Use within the physician office setting by the medical professional - Resting ECG monitoring (using Bluetooth communication) - Telemetry ECG monitoring (using Bluetooth communication) Such monitoring is most frequently used for the indications below: • Evaluation of symptoms suggesting arrhythmia or myocardial ischemia • Evaluation of ECG documenting therapeutic…
Read the full statement (125 words)
The NR recorder is intended for patients requiring:
• Ambulatory (Holter) monitoring
• Use within the physician office setting by the medical professional
- Resting ECG monitoring (using Bluetooth communication)
- Telemetry ECG monitoring (using Bluetooth communication)
Such monitoring is most frequently used for the indications below:
• Evaluation of symptoms suggesting arrhythmia or myocardial ischemia
• Evaluation of ECG documenting therapeutic interventions in individual patients or groups of patients
• Evaluation of patients for ST segment changes
• Evaluation of a patient's response after resuming occupational or recreational activities (for example, after myocardial infarction or cardiac surgery)
• Clinical and epidemiological research studies
• Evaluation of patients with pacemakers
• Reporting of time and frequency domain heart rate variability
• Reporting of QT interval
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K161062 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161062: NR Recorder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161062
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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