Cascade IOMAX
Model 199291-200 · CADWELL INDUSTRIES, INC. · DI 00840067102831
DQA — Oximeter · Class II · 21 CFR 870.2700
ETN — Stimulator, Nerve · Class II · 21 CFR 874.1820
GWE — Stimulator, Photic, Evoked Response · Class II · 21 CFR 882.1890
GWF — Stimulator, Electrical, Evoked Response · Class II · 21 CFR 882.1870
GWJ — Stimulator, Auditory, Evoked Response · Class II · 21 CFR 882.1900
GWQ — Full-Montage Standard Electroencephalograph · Class II · 21 CFR 882.1400
GZO — Device, Galvanic Skin Response Measurement · Class II · 21 CFR 882.1540
IKN — Electromyograph, Diagnostic · Class II · 21 CFR 890.1375
JXE — Device, Nerve Conduction Velocity Measurement · Class II · 21 CFR 882.1550
OLT — Non-Normalizing Quantitative Electroencephalograph Software · Class II · 21 CFR 882.1400
UDILibrary device dossier · generated 2026-09-12 · 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 | 6.07 |
| 2019-02 | 0 | 7.66 |
| 2019-03 | 0 | 5.91 |
| 2019-04 | 0 | 4.33 |
| 2019-05 | 0 | 4.38 |
| 2019-06 | 0 | 3.8 |
| 2019-07 | 0 | 4.16 |
| 2019-08 | 0 | 5.93 |
| 2019-09 | 0 | 5.37 |
| 2019-10 | 0 | 5.68 |
| 2019-11 | 0 | 6.08 |
| 2019-12 | 0 | 5.98 |
| 2020-01 | 0 | 4.91 |
| 2020-02 | 0 | 4.78 |
| 2020-03 | 0 | 5.31 |
| 2020-04 | 0 | 5.85 |
| 2020-05 | 0 | 5.05 |
| 2020-06 | 0 | 4.53 |
| 2020-07 | 0 | 5.47 |
| 2020-08 | 0 | 4.85 |
| 2020-09 | 0 | 5.8 |
| 2020-10 | 0 | 6.91 |
| 2020-11 | 0 | 6.32 |
| 2020-12 | 0 | 6.46 |
| 2021-01 | 0 | 6.24 |
| 2021-02 | 0 | 7.59 |
| 2021-03 | 0 | 8.15 |
| 2021-04 | 0 | 4.69 |
| 2021-05 | 0 | 4.73 |
| 2021-06 | 0 | 5.16 |
| 2021-07 | 0 | 5.64 |
| 2021-08 | 0 | 4.51 |
| 2021-09 | 0 | 6.32 |
| 2021-10 | 0 | 5.65 |
| 2021-11 | 0 | 6.4 |
| 2021-12 | 0 | 4.61 |
| 2022-01 | 0 | 4.74 |
| 2022-02 | 0 | 4.69 |
| 2022-03 | 0 | 7.61 |
| 2022-04 | 0 | 6.47 |
| 2022-05 | 0 | 6.6 |
| 2022-06 | 0 | 6.4 |
| 2022-07 | 0 | 3.72 |
| 2022-08 | 0 | 5.17 |
| 2022-09 | 0 | 6.41 |
| 2022-10 | 0 | 8.69 |
| 2022-11 | 0 | 5.62 |
| 2022-12 | 0 | 5.26 |
| 2023-01 | 0 | 5.07 |
| 2023-02 | 0 | 7.33 |
| 2023-03 | 0 | 9.56 |
| 2023-04 | 0 | 8.45 |
| 2023-05 | 0 | 11.07 |
| 2023-06 | 0 | 7.54 |
| 2023-07 | 0 | 11.53 |
| 2023-08 | 0 | 13.98 |
| 2023-09 | 0 | 14.76 |
| 2023-10 | 0 | 11.31 |
| 2023-11 | 0 | 12.63 |
| 2023-12 | 0 | 13.97 |
| 2024-01 | 0 | 13.21 |
| 2024-02 | 0 | 12.35 |
| 2024-03 | 0 | 13.54 |
| 2024-04 | 0 | 11.38 |
| 2024-05 | 0 | 11.91 |
| 2024-06 | 0 | 9.87 |
| 2024-07 | 0 | 15.56 |
| 2024-08 | 0 | 14.01 |
| 2024-09 | 0 | 19.98 |
| 2024-10 | 0 | 20.15 |
| 2024-11 | 0 | 16.52 |
| 2024-12 | 0 | 12.02 |
| 2025-01 | 0 | 14.34 |
| 2025-02 | 0 | 15.37 |
| 2025-03 | 0 | 17.08 |
| 2025-04 | 0 | 11.7 |
| 2025-05 | 0 | 9.56 |
| 2025-06 | 0 | 8.6 |
| 2025-07 | 0 | 12.53 |
| 2025-08 | 0 | 8.12 |
| 2025-09 | 0 | 8.29 |
| 2025-10 | 0 | 12.84 |
| 2025-11 | 0 | 9.7 |
| 2025-12 | 0 | 10.25 |
| 2026-01 | 0 | 8.86 |
| 2026-02 | 0 | 8.95 |
| 2026-03 | 0 | 10.46 |
| 2026-04 | 0 | 17.74 |
| 2026-05 | 0 | 13.4 |
| 2026-06 | 0 | 11.35 |
Regulatory clearances
- None linked in the loaded window.
Predicate lineage
K162199 — cites (transitively): K020400 (d1), K040358 (d1), K051357 (d1), K072964 (d1), K083124 (d1), K093304 (d1), K112718 (d1), K120979 (d1), K141105 (d1), K142624 (d1), K143641 (d1), K152563 (d1), K971214 (d1), K022914 (d2), K050438 (d2), K962455 (d2), K921927 (d2), K965065 (d2), K130947 (d2), K139047 (d2), K050798 (d2), K051178 (d2), K053363 (d2), K061173 (d2), K071969 (d2), K110410 (d2), K111647 (d2), K120397 (d2), K850342 (d2), K141968 (d2), K090599 (d2), K924226 (d3), K083242 (d3), K964869 (d3), K980148 (d3), K991583 (d3), K992869 (d3), K991899 (d3), K051107 (d3), K132694 (d3), K092744 (d4), K123307 (d4), K122742 (d5), K033621 (d6) — cited as predicate by K181466, K212166, K230415, K234092
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — CADWELL INDUSTRIES, INC.
- VAI 2017-08-16 Cadwell Industries Inc · 3 citations
- VAI 2017-08-16 Cadwell Industries Inc · 3 citations
- VAI 2013-04-30 Cadwell Industries Inc · 3 citations
- VAI 2013-04-30 Cadwell Industries Inc · 3 citations