Alamo C
Model 2016T-207 · ALLIANCE PARTNERS LLC · DI M6862016T2070
HTR — Rasp · Class I · 21 CFR 878.4800
HWT — Template · Class I · 21 CFR 888.4800
UDILibrary device dossier · generated 2026-09-07 · 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 | 1.42 |
| 2019-02 | 0 | 1.95 |
| 2019-03 | 0 | 1.7 |
| 2019-04 | 0 | 1.65 |
| 2019-05 | 0 | 2.3 |
| 2019-06 | 0 | 1.42 |
| 2019-07 | 0 | 1.53 |
| 2019-08 | 0 | 1.4 |
| 2019-09 | 0 | 1.5 |
| 2019-10 | 0 | 2.57 |
| 2019-11 | 0 | 1.7 |
| 2019-12 | 0 | 1.85 |
| 2020-01 | 0 | 1.76 |
| 2020-02 | 0 | 1.57 |
| 2020-03 | 0 | 1.67 |
| 2020-04 | 0 | 1.63 |
| 2020-05 | 0 | 1.39 |
| 2020-06 | 0 | 1.67 |
| 2020-07 | 0 | 1.8 |
| 2020-08 | 0 | 1.87 |
| 2020-09 | 0 | 1.64 |
| 2020-10 | 0 | 1.89 |
| 2020-11 | 0 | 1.76 |
| 2020-12 | 0 | 1.67 |
| 2021-01 | 0 | 1.54 |
| 2021-02 | 0 | 2.15 |
| 2021-03 | 0 | 1.9 |
| 2021-04 | 0 | 1.89 |
| 2021-05 | 0 | 1.79 |
| 2021-06 | 0 | 2 |
| 2021-07 | 0 | 2.08 |
| 2021-08 | 0 | 1.61 |
| 2021-09 | 0 | 2.1 |
| 2021-10 | 0 | 1.77 |
| 2021-11 | 0 | 1.62 |
| 2021-12 | 0 | 1.83 |
| 2022-01 | 0 | 1.52 |
| 2022-02 | 0 | 1.75 |
| 2022-03 | 0 | 2.04 |
| 2022-04 | 0 | 1.57 |
| 2022-05 | 0 | 1.27 |
| 2022-06 | 0 | 1.84 |
| 2022-07 | 0 | 2.66 |
| 2022-08 | 0 | 1.65 |
| 2022-09 | 0 | 1.64 |
| 2022-10 | 0 | 2.92 |
| 2022-11 | 0 | 1.49 |
| 2022-12 | 0 | 1.91 |
| 2023-01 | 0 | 2.32 |
| 2023-02 | 0 | 2.02 |
| 2023-03 | 0 | 2.17 |
| 2023-04 | 0 | 1.99 |
| 2023-05 | 0 | 1.84 |
| 2023-06 | 0 | 1.6 |
| 2023-07 | 0 | 1.92 |
| 2023-08 | 0 | 1.73 |
| 2023-09 | 0 | 1.32 |
| 2023-10 | 0 | 1.52 |
| 2023-11 | 0 | 2.23 |
| 2023-12 | 0 | 1.5 |
| 2024-01 | 0 | 1.88 |
| 2024-02 | 0 | 2.09 |
| 2024-03 | 0 | 1.64 |
| 2024-04 | 0 | 1.51 |
| 2024-05 | 0 | 1.85 |
| 2024-06 | 0 | 1.91 |
| 2024-07 | 0 | 1.77 |
| 2024-08 | 0 | 1.58 |
| 2024-09 | 0 | 1.56 |
| 2024-10 | 0 | 1.85 |
| 2024-11 | 0 | 1.98 |
| 2024-12 | 0 | 1.62 |
| 2025-01 | 0 | 1.56 |
| 2025-02 | 0 | 1.44 |
| 2025-03 | 0 | 1.52 |
| 2025-04 | 0 | 1.51 |
| 2025-05 | 0 | 1.74 |
| 2025-06 | 0 | 1.79 |
| 2025-07 | 0 | 1.8 |
| 2025-08 | 0 | 1.47 |
| 2025-09 | 0 | 1.43 |
| 2025-10 | 0 | 2.44 |
| 2025-11 | 0 | 2.85 |
| 2025-12 | 0 | 2.03 |
| 2026-01 | 0 | 1.92 |
| 2026-02 | 0 | 2.12 |
| 2026-03 | 0 | 1.69 |
| 2026-04 | 0 | 1.89 |
| 2026-05 | 0 | 1.73 |
| 2026-06 | 0 | 1.86 |
Regulatory clearances
- None linked in the loaded window.
Predicate lineage
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