Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 2 |
| 2019-02 | 0 | 1 |
| 2019-04 | 0 | 3 |
| 2019-05 | 0 | 3 |
| 2019-06 | 0 | 1 |
| 2019-07 | 0 | 1 |
| 2019-08 | 0 | 1 |
| 2019-09 | 0 | 1 |
| 2019-10 | 0 | 3 |
| 2019-11 | 0 | 4 |
| 2019-12 | 0 | 3 |
| 2020-01 | 0 | 2 |
| 2020-02 | 1 | 1 |
| 2020-03 | 0 | 3 |
| 2020-04 | 0 | 5 |
| 2020-05 | 0 | 2 |
| 2020-10 | 0 | 1 |
| 2021-01 | 1 | 1 |
| 2021-02 | 0 | 1 |
| 2021-04 | 2 | 2 |
| 2021-07 | 0 | 1 |
| 2021-11 | 1 | 1 |
| 2022-02 | 0 | 3 |
| 2022-05 | 0 | 2 |
| 2022-06 | 1 | 1 |
| 2022-07 | 0 | 1 |
| 2022-08 | 0 | 2 |
| 2022-09 | 0 | 1 |
| 2022-10 | 0 | 3 |
| 2023-01 | 0 | 3 |
| 2023-02 | 0 | 3 |
| 2023-03 | 0 | 3 |
| 2023-08 | 0 | 2 |
| 2023-12 | 0 | 3.67 |
| 2024-01 | 0 | 4.75 |
| 2024-02 | 1 | 1 |
| 2024-06 | 0 | 1 |
| 2024-08 | 0 | 1 |
| 2024-09 | 0 | 2 |
| 2024-11 | 0 | 3 |
| 2025-05 | 0 | 1 |
| 2025-08 | 0 | 2 |
| 2025-10 | 0 | 1 |
| 2025-11 | 0 | 1 |
| 2025-12 | 0 | 2 |
7 linked report narratives available — no AI summary generated yet.
No recalls linked.
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2024-02-27 | 2084725-2024-00009 | Malfunction | Available | exact di |
| 2022-06-22 | 2084725-2022-00190 | Malfunction | Available | exact di |
| 2021-11-18 | 2084725-2021-00405 | Malfunction | Available | exact di |
| 2021-04-16 | 2084725-2021-00116 | Malfunction | Available | exact di |
| 2021-04-07 | 2084725-2021-00098 | Malfunction | Available | exact di |
| 2021-01-25 | 2084725-2021-00009 | Malfunction | Available | exact di |
| 2020-02-21 | 2084725-2020-00015 | Malfunction | Available | exact di |
- 510(k)K192025Substantially equivalent (SESE) · 2020-01-23clearance family
- 510(k)K170039Substantially equivalent (SESE) · 2017-06-20clearance family
Predicate lineage
Cited as predicate by: K182404
- K192025
Cited as predicate by: K234084
Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.
None in the loaded window.
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