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"Neo-Pod™ ""T"""
Model 9403U · WESTMED, INC. · DI 00709078005022
BTT — Humidifier, Respiratory Gas, (Direct Patient Interface) · Class II · 21 CFR 868.5450
UDILibrary device dossier · generated 2026-09-07 · 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)
2019-01
0
4.5
2019-02
0
4.5
2019-03
0
10
2019-04
0
5.4
2019-05
0
3.75
2019-06
0
7.33
2019-07
0
4.5
2019-08
0
4.44
2019-09
0
5.25
2019-10
0
4.67
2019-11
0
7
2019-12
0
4.5
2020-01
0
8.5
2020-02
0
4.67
2020-03
0
2.5
2020-04
0
4
2020-05
0
2
2020-06
0
1.75
2020-07
0
2
2020-08
0
2
2020-09
0
1.67
2020-10
0
1.6
2020-11
0
3
2020-12
0
2.67
2021-01
0
2.45
2021-02
0
7.22
2021-03
0
16.25
2021-04
0
5.85
2021-05
0
7.13
2021-06
0
7
2021-07
0
4.38
2021-08
0
8.38
2021-09
0
5.5
2021-10
0
7.43
2021-11
0
8.91
2021-12
0
9.79
2022-01
0
5.72
2022-02
0
8.5
2022-03
0
5.57
2022-04
0
4.3
2022-05
0
3.87
2022-06
0
5.33
2022-07
0
4.07
2022-08
0
5.27
2022-09
0
3.64
2022-10
0
4.33
2022-11
0
3.35
2022-12
0
4.56
2023-01
0
3.73
2023-02
0
4
2023-03
0
5.68
2023-04
0
4.85
2023-05
0
3.33
2023-06
0
7.5
2023-07
0
5.07
2023-08
0
4.57
2023-09
0
5.67
2023-10
0
3.44
2023-11
0
4.18
2023-12
0
4.73
2024-01
0
3
2024-02
0
3.58
2024-03
0
3.5
2024-04
0
3.79
2024-05
0
3
2024-06
0
3.72
2024-07
0
4.26
2024-08
0
4.83
2024-09
0
3.57
2024-10
0
4
2024-11
0
4.87
2024-12
0
5.56
2025-01
0
3.86
2025-02
0
4.56
2025-03
0
4.47
2025-04
0
6.6
2025-05
0
4.94
2025-06
0
4.78
2025-07
0
5.21
2025-08
0
6
2025-09
0
6.04
2025-10
0
14.55
2025-11
0
29.76
2025-12
0
22.32
2026-01
0
15.56
2026-02
0
15.09
2026-03
0
20.1
2026-04
0
22.21
2026-05
0
14.27
2026-06
0
10.13
This device (reports/month)Average device in BTT (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Predicate lineage
K870173 — cited as predicate by K141565
Lineage extracted from public 510(k) summary text (heuristic).