Alamo C
Model 1412T-300 · ALLIANCE PARTNERS LLC · DI M6861412T3000
HWA — Impactor · Class I · 21 CFR 888.4540
UDILibrary device dossier · generated 2026-09-13 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (0)
No recalls linked in the loaded window.
Adverse-event reports — MAUDE (0)
Caveat (required reading): 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 is a reporting baseline (average device in the same product code), not a risk measure.
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 8.04 |
| 2019-02 | 0 | 10.7 |
| 2019-03 | 0 | 9 |
| 2019-04 | 0 | 6.8 |
| 2019-05 | 0 | 5.96 |
| 2019-06 | 0 | 6.11 |
| 2019-07 | 0 | 7.09 |
| 2019-08 | 0 | 6.59 |
| 2019-09 | 0 | 5.29 |
| 2019-10 | 0 | 8.2 |
| 2019-11 | 0 | 7.87 |
| 2019-12 | 0 | 7.83 |
| 2020-01 | 0 | 9.32 |
| 2020-02 | 0 | 5.8 |
| 2020-03 | 0 | 7.52 |
| 2020-04 | 0 | 3.87 |
| 2020-05 | 0 | 3.5 |
| 2020-06 | 0 | 5.84 |
| 2020-07 | 0 | 7.81 |
| 2020-08 | 0 | 7.86 |
| 2020-09 | 0 | 5.17 |
| 2020-10 | 0 | 8.95 |
| 2020-11 | 0 | 4.21 |
| 2020-12 | 0 | 8.39 |
| 2021-01 | 0 | 6.96 |
| 2021-02 | 0 | 5.95 |
| 2021-03 | 0 | 7.27 |
| 2021-04 | 0 | 6.14 |
| 2021-05 | 0 | 8.33 |
| 2021-06 | 0 | 7.67 |
| 2021-07 | 0 | 6.87 |
| 2021-08 | 0 | 6.42 |
| 2021-09 | 0 | 8.69 |
| 2021-10 | 0 | 7.78 |
| 2021-11 | 0 | 8.14 |
| 2021-12 | 0 | 6.94 |
| 2022-01 | 0 | 7.29 |
| 2022-02 | 0 | 4.93 |
| 2022-03 | 0 | 6.89 |
| 2022-04 | 0 | 7.73 |
| 2022-05 | 0 | 5.97 |
| 2022-06 | 0 | 6.34 |
| 2022-07 | 0 | 7.3 |
| 2022-08 | 0 | 6.86 |
| 2022-09 | 0 | 5.8 |
| 2022-10 | 0 | 6.3 |
| 2022-11 | 0 | 7.67 |
| 2022-12 | 0 | 9 |
| 2023-01 | 0 | 9.32 |
| 2023-02 | 0 | 7.11 |
| 2023-03 | 0 | 7.28 |
| 2023-04 | 0 | 6.58 |
| 2023-05 | 0 | 6.32 |
| 2023-06 | 0 | 5.81 |
| 2023-07 | 0 | 7.59 |
| 2023-08 | 0 | 5.71 |
| 2023-09 | 0 | 4.29 |
| 2023-10 | 0 | 6.9 |
| 2023-11 | 0 | 6.06 |
| 2023-12 | 0 | 4.94 |
| 2024-01 | 0 | 6.59 |
| 2024-02 | 0 | 7.17 |
| 2024-03 | 0 | 4.73 |
| 2024-04 | 0 | 5.58 |
| 2024-05 | 0 | 5.3 |
| 2024-06 | 0 | 5 |
| 2024-07 | 0 | 4.68 |
| 2024-08 | 0 | 5.25 |
| 2024-09 | 0 | 5.16 |
| 2024-10 | 0 | 6.49 |
| 2024-11 | 0 | 5.26 |
| 2024-12 | 0 | 5.42 |
| 2025-01 | 0 | 6.08 |
| 2025-02 | 0 | 4.36 |
| 2025-03 | 0 | 4.71 |
| 2025-04 | 0 | 4.73 |
| 2025-05 | 0 | 5.52 |
| 2025-06 | 0 | 5.73 |
| 2025-07 | 0 | 6.5 |
| 2025-08 | 0 | 5.55 |
| 2025-09 | 0 | 4.73 |
| 2025-10 | 0 | 4.49 |
| 2025-11 | 0 | 5.7 |
| 2025-12 | 0 | 6.43 |
| 2026-01 | 0 | 5.54 |
| 2026-02 | 0 | 5.05 |
| 2026-03 | 0 | 5.37 |
| 2026-04 | 0 | 6.24 |
| 2026-05 | 0 | 5.06 |
| 2026-06 | 0 | 5.5 |
Regulatory clearances
- None linked in the loaded window.
Predicate lineage
K112361 — cited as predicate by K173128
K133321 — cites (transitively): K081917 (d1) — cited as predicate by K173128
K173128 — cites (transitively): K111272 (d1), K112361 (d1), K133321 (d1), K141993 (d1), K161127 (d1), K071833 (d2), K092521 (d2), K081917 (d2), K091134 (d2), K100243 (d2) — cited as predicate by K213115, K252737
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — ALLIANCE PARTNERS LLC
- NAI 2017-09-20 Alliance Partners LLC · 0 citations
- NAI 2013-06-14 Alliance Partners LLC · 0 citations