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BUBBLE HUMIDIFIER 400cc (6 psi), DISPOSABLE
Model HB-72462 · BESMED HEALTH BUSINESS CORP. · DI 04716770724621
KFZ — Humidifier, Non-Direct Patient Interface (Home-Use) · Class I · 21 CFR 868.5460
UDILibrary device dossier · generated 2026-09-14 · 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)
2020-02
0
1
2020-10
0
1
2020-12
0
1
2021-06
0
1
2021-07
0
1
2021-08
0
1
2021-10
0
2
2021-11
0
1.5
2022-01
0
1.33
2022-04
0
1
2022-06
0
1
2022-10
0
1
2022-12
0
1
2023-03
0
1
2023-04
0
1
2023-07
0
1
2023-08
0
1
2023-09
0
1
2023-11
0
1
2024-01
0
1
2024-03
0
1
2024-05
0
1
2024-07
0
1
2024-08
0
1
2025-01
0
1
2025-03
0
1
2025-04
0
1
2025-05
0
1
2025-10
0
1
2025-12
0
1
2026-01
0
1
2026-02
0
1
2026-04
0
1
2026-06
0
1
This device (reports/month)Average device in KFZ (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — BESMED HEALTH BUSINESS CORP.