Model NB-31740 · BESMED HEALTH BUSINESS CORP. · DI 04716770317403
CAF — Nebulizer (Direct Patient Interface) · Class II · 21 CFR 868.5630
UDILibrary device dossier · generated 2026-09-11 · 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
2
2019-02
0
1
2019-03
0
1
2019-04
0
2.5
2019-06
0
1
2019-09
0
1
2019-10
0
1
2019-11
0
1
2020-01
0
1.75
2020-02
0
2
2020-03
0
1
2020-04
0
1.5
2020-07
0
1.5
2020-08
0
1
2020-09
0
1
2020-10
0
1
2020-11
0
1
2020-12
0
1.5
2021-01
0
1.5
2021-02
0
3.25
2021-03
0
1.5
2021-04
0
3.71
2021-05
0
1
2021-06
0
1.67
2021-07
0
16.33
2021-08
0
3.6
2021-09
0
1
2021-10
0
1
2021-11
0
1
2021-12
0
1
2022-01
0
2
2022-02
0
1
2022-03
0
1.5
2022-04
0
1.33
2022-05
0
4.33
2022-06
0
2
2022-07
0
1
2022-08
0
1
2022-09
0
2.08
2022-10
0
1.5
2022-11
0
2
2022-12
0
2
2023-01
0
1.67
2023-02
0
1.8
2023-04
0
2
2023-05
0
1.67
2023-06
0
1.5
2023-07
0
2.2
2023-08
0
2
2023-10
0
1.25
2023-11
0
1.38
2023-12
0
2.5
2024-01
0
1.4
2024-02
0
2.67
2024-03
0
1.75
2024-04
0
2.57
2024-05
0
1.6
2024-06
0
4
2024-07
0
1.38
2024-08
0
3
2024-09
0
2.2
2024-10
0
6.1
2024-11
0
2.67
2024-12
0
1.92
2025-01
0
3.33
2025-02
0
2.63
2025-03
0
1.67
2025-04
0
2
2025-05
0
2.83
2025-06
0
3.2
2025-07
0
1
2025-08
0
5
2025-09
0
3
2025-10
0
4.5
2025-11
0
3.25
2025-12
0
4.67
2026-01
0
5.5
2026-02
0
7.25
2026-03
0
13.5
2026-04
0
12
2026-05
0
20.67
2026-06
0
13
This device (reports/month)Average device in CAF (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Predicate lineage
K091272 — cited as predicate by K112041, K161586, K212395
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — BESMED HEALTH BUSINESS CORP.