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NATUS NEUROLOGY

Model 515-020300 · NATUS NEUROLOGY INCORPORATED · DI 00382830037044

IKN — Electromyograph, Diagnostic · Class II · 21 CFR 890.1375

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.

23562019-01: 0 reports for this device; peer average 1/device2019-04: 0 reports for this device; peer average 1/device2019-06: 0 reports for this device; peer average 1/device2019-09: 0 reports for this device; peer average 2/device2019-10: 0 reports for this device; peer average 1/device2021-05: 0 reports for this device; peer average 2/device2021-10: 0 reports for this device; peer average 6/device2021-11: 0 reports for this device; peer average 2/device2022-02: 0 reports for this device; peer average 2/device2022-03: 0 reports for this device; peer average 2/device2022-04: 0 reports for this device; peer average 3/device2022-05: 0 reports for this device; peer average 1.67/device2022-07: 0 reports for this device; peer average 4/device2022-08: 0 reports for this device; peer average 2/device2022-09: 0 reports for this device; peer average 1/device2022-10: 0 reports for this device; peer average 4/device2022-11: 0 reports for this device; peer average 4/device2022-12: 0 reports for this device; peer average 2.67/device2023-01: 0 reports for this device; peer average 1/device2023-03: 0 reports for this device; peer average 3.33/device2023-05: 0 reports for this device; peer average 2/device2023-08: 0 reports for this device; peer average 2/device2023-09: 0 reports for this device; peer average 2/device2023-10: 0 reports for this device; peer average 4/device2023-11: 0 reports for this device; peer average 2/device2024-01: 0 reports for this device; peer average 2/device2024-02: 0 reports for this device; peer average 1.5/device2024-04: 0 reports for this device; peer average 1/device2024-10: 0 reports for this device; peer average 1.5/device2025-04: 0 reports for this device; peer average 1/device2025-07: 0 reports for this device; peer average 4/device2025-08: 0 reports for this device; peer average 2/device2025-12: 0 reports for this device; peer average 4/device2026-01: 0 reports for this device; peer average 3/device2026-02: 0 reports for this device; peer average 2/device2026-03: 0 reports for this device; peer average 2/device2026-04: 0 reports for this device; peer average 2/device2026-05: 0 reports for this device; peer average 2/device0104060910051011020304050708091011120103050809101101020410040708120102030405
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101
2019-0401
2019-0601
2019-0902
2019-1001
2021-0502
2021-1006
2021-1102
2022-0202
2022-0302
2022-0403
2022-0501.67
2022-0704
2022-0802
2022-0901
2022-1004
2022-1104
2022-1202.67
2023-0101
2023-0303.33
2023-0502
2023-0802
2023-0902
2023-1004
2023-1102
2024-0102
2024-0201.5
2024-0401
2024-1001.5
2025-0401
2025-0704
2025-0802
2025-1204
2026-0103
2026-0202
2026-0302
2026-0402
2026-0502
This device (reports/month)Average device in IKN (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K112052 — cites (transitively): K010590 (d1), K102610 (d1), K890495 (d1), K924723 (d1), K965065 (d1), K984052 (d1), K991054 (d1), K060584 (d2), K073415 (d2), K981405 (d2) — cited as predicate by K141316, K162383, K171781, K200705

Lineage extracted from public 510(k) summary text (heuristic).

Manufacturer compliance record — NATUS NEUROLOGY INCORPORATED

  • NAI 2014-07-18 Natus Neurology Inc · 0 citations
  • NAI 2010-11-17 Natus Neurology Inc · 0 citations