ARES 610 Home Sleep Test Accessories - 50 Pack
Model 610 · Watermark Medical, Inc. · DI 00854485007111
ETN — Stimulator, Nerve · Class II · 21 CFR 874.1820
NFB — Conserver, Oxygen · Class II · 21 CFR 868.5905
UDILibrary device dossier · generated 2026-09-06 · 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 | 2.71 |
| 2019-02 | 0 | 3.5 |
| 2019-03 | 0 | 2.8 |
| 2019-04 | 0 | 1.75 |
| 2019-05 | 0 | 2.27 |
| 2019-06 | 0 | 1.56 |
| 2019-07 | 0 | 1.53 |
| 2019-08 | 0 | 3.77 |
| 2019-09 | 0 | 2.71 |
| 2019-10 | 0 | 3.56 |
| 2019-11 | 0 | 3.79 |
| 2019-12 | 0 | 4.23 |
| 2020-01 | 0 | 2.65 |
| 2020-02 | 0 | 1.91 |
| 2020-03 | 0 | 3.32 |
| 2020-04 | 0 | 2.39 |
| 2020-05 | 0 | 1.5 |
| 2020-06 | 0 | 1.63 |
| 2020-07 | 0 | 2.13 |
| 2020-08 | 0 | 2.69 |
| 2020-09 | 0 | 2.65 |
| 2020-10 | 0 | 3.66 |
| 2020-11 | 0 | 2.63 |
| 2020-12 | 0 | 2.42 |
| 2021-01 | 0 | 1.14 |
| 2021-02 | 0 | 2 |
| 2021-03 | 0 | 1.65 |
| 2021-04 | 0 | 1.82 |
| 2021-05 | 0 | 1.52 |
| 2021-06 | 0 | 2.11 |
| 2021-07 | 0 | 2.59 |
| 2021-08 | 0 | 2.24 |
| 2021-09 | 0 | 3.6 |
| 2021-10 | 0 | 2.45 |
| 2021-11 | 0 | 1.79 |
| 2021-12 | 0 | 1.48 |
| 2022-01 | 0 | 1.95 |
| 2022-02 | 0 | 1.76 |
| 2022-03 | 0 | 1.35 |
| 2022-04 | 0 | 2.33 |
| 2022-05 | 0 | 2.78 |
| 2022-06 | 0 | 2.11 |
| 2022-07 | 0 | 1.69 |
| 2022-08 | 0 | 2.16 |
| 2022-09 | 0 | 2.14 |
| 2022-10 | 0 | 2.3 |
| 2022-11 | 0 | 2 |
| 2022-12 | 0 | 1.87 |
| 2023-01 | 0 | 2.6 |
| 2023-02 | 0 | 2.02 |
| 2023-03 | 0 | 2.43 |
| 2023-04 | 0 | 1.8 |
| 2023-05 | 0 | 2.31 |
| 2023-06 | 0 | 2.31 |
| 2023-07 | 0 | 1.73 |
| 2023-08 | 0 | 2.76 |
| 2023-09 | 0 | 3.18 |
| 2023-10 | 0 | 6.98 |
| 2023-11 | 0 | 5.55 |
| 2023-12 | 0 | 7.02 |
| 2024-01 | 0 | 5.24 |
| 2024-02 | 0 | 6.65 |
| 2024-03 | 0 | 5.45 |
| 2024-04 | 0 | 7.76 |
| 2024-05 | 0 | 7.8 |
| 2024-06 | 0 | 5.96 |
| 2024-07 | 0 | 9.32 |
| 2024-08 | 0 | 12.11 |
| 2024-09 | 0 | 15.27 |
| 2024-10 | 0 | 13.26 |
| 2024-11 | 0 | 11.41 |
| 2024-12 | 0 | 8.76 |
| 2025-01 | 0 | 8.61 |
| 2025-02 | 0 | 16.3 |
| 2025-03 | 0 | 11.36 |
| 2025-04 | 0 | 10.76 |
| 2025-05 | 0 | 8.22 |
| 2025-06 | 0 | 8.79 |
| 2025-07 | 0 | 16.26 |
| 2025-08 | 0 | 8.4 |
| 2025-09 | 0 | 9.59 |
| 2025-10 | 0 | 14.53 |
| 2025-11 | 0 | 12.14 |
| 2025-12 | 0 | 11.7 |
| 2026-01 | 0 | 9.32 |
| 2026-02 | 0 | 8 |
| 2026-03 | 0 | 11.18 |
| 2026-04 | 0 | 10.69 |
| 2026-05 | 0 | 10.77 |
| 2026-06 | 0 | 12.25 |
Regulatory clearances
- None linked in the loaded window.
Predicate lineage
K110705 — cites (transitively): K071230 (d1) — cited as predicate by K111194
K111194 — cites (transitively): K021176 (d1), K071230 (d1), K072201 (d1), K090484 (d1), K110705 (d1) — cited as predicate by K112514, K160499
K112514 — cites (transitively): K082968 (d1), K111194 (d1), K021176 (d2), K071230 (d2), K072201 (d2), K090484 (d2), K110705 (d2) — cited as predicate by K120447, K120450, K130007, K130013, K140190, K152040, K153412
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — Watermark Medical, Inc.
- NAI 2017-07-05 Watermark Medical · 0 citations
- NAI 2017-07-05 Watermark Medical · 0 citations