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ATLAS ANALOG ISOLATOR
Model ATLAS ANALOG ISOLATOR · NEURALYNX, INC. · DI 00850011306161
OMC — Reduced- Montage Standard Electroencephalograph · 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.
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2021-09
0
2
2021-10
0
1
2022-05
0
1
2023-05
0
4.33
2024-04
0
1
2024-09
0
1
2025-01
0
1
2025-02
0
2
2025-03
0
2
2025-04
0
2
2025-06
0
1.25
2025-07
0
1
2025-08
0
2
2025-10
0
1
2025-11
0
1
2025-12
0
1
2026-01
0
3
2026-02
0
4
2026-03
0
3
2026-04
0
4.5
2026-05
0
1.5
2026-06
0
2
This device (reports/month)Average device in OMC (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Predicate lineage
K110967 — cites (transitively): K053363 (d1), K060523 (d1), K082474 (d1) — cited as predicate by K250094
Lineage extracted from public 510(k) summary text (heuristic).