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) |
|---|---|---|
| 2019-07 | 0 | 1 |
| 2021-02 | 0 | 7 |
| 2023-03 | 0 | 1 |
| 2024-06 | 0 | 2 |
| 2024-11 | 0 | 1 |
| 2025-10 | 3 | 2 |
| 2026-03 | 0 | 3 |
3 linked report narratives available — no AI summary generated yet.
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2019-07-09 | Z-2397-2019 | Class II | Terminated | code 7-102 Liquid Sensor ErrorDistribution: US Nationwide Distribution in the states of CA CO FL GA HI IL IN KS KY MA MD MI MO NC NJ NV NY OH OK OR PA TN TX UT VA WA | 387 Instruments | code info di |
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2025-10-15 | 3004973408-2025-00002 | Malfunction | Available | catalog number |
Showing the most recent 1 of 3 linked reports.
Predicate lineage
Cited as predicate by: K151029, K182479, K190315, K191510, K200279, K200825, K212181, K220162, K242531, K252493, K252775, K260059, K260280, K260591, K261027
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.
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2013-11-21 | NAI | No action indicated | Phadia GmbH | 0 |
| 2011-08-18 | NAI | No action indicated | Phadia Ab | 0 |
| 2011-08-18 | NAI | No action indicated | Phadia Ab | 0 |
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