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AASM Headbox
Model TOS094 · SOMNOmedics AG · DI 04250413404452
MNR — Ventilatory Effort Recorder · Class II · 21 CFR 868.2375
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.
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2020-03
0
1
2020-06
0
1
2020-07
0
1
2021-03
0
2
2021-10
0
2
2021-12
0
2
2022-01
0
2
2022-05
0
1
2022-09
0
1
2023-01
0
1
2023-02
0
1
2023-07
0
2
2023-08
0
1
2023-12
0
1
2024-01
0
4
2024-03
0
2
2024-08
0
9
2025-01
0
2
2025-02
0
2
2025-03
0
2
2025-05
0
2
2025-07
0
6
2025-10
0
2
2025-11
0
6
2025-12
0
2
2026-01
0
6
This device (reports/month)Average device in MNR (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Predicate lineage
K140861 — cites (transitively): K060708 (d1) — cited as predicate by K223163
Lineage extracted from public 510(k) summary text (heuristic).