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AirLife™
Model 2074816-001 · AirLife Finland Oy · DI 10889483577363
FMZ — Incubator, Neonatal · Class II · 21 CFR 880.5400
UDILibrary device dossier · generated 2026-09-15 · 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 (3)
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.
Malfunction: 3
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-07
0
1
2019-08
0
1
2019-09
0
1
2019-10
0
2
2020-02
0
1
2020-03
0
1
2020-08
0
1
2020-10
0
1
2020-12
0
1
2021-06
0
1
2021-08
0
2
2021-09
0
1.5
2021-11
0
1
2021-12
0
1
2022-01
0
1
2022-03
0
1
2022-04
0
1
2022-06
0
1
2022-07
0
1
2022-08
0
1
2022-09
0
1
2022-10
0
1
2022-11
0
4
2022-12
0
3
2023-01
0
1
2023-03
0
1
2023-04
0
1
2023-06
0
1.5
2023-07
0
2
2023-11
0
1
2023-12
0
1
2024-01
0
2
2024-02
0
1.5
2024-03
0
1.5
2024-04
0
1
2024-06
0
1.5
2024-07
0
3
2024-08
0
5
2024-09
0
2.5
2024-10
0
2.5
2024-11
0
16
2024-12
0
12.5
2025-01
0
21
2025-02
0
19
2025-03
0
19
2025-04
0
21
2025-05
0
12
2025-06
0
18.5
2025-07
0
13
2025-08
0
17
2025-09
0
8
2025-10
0
6.5
2025-11
0
7
2025-12
0
12
2026-01
0
6
2026-02
0
4.67
2026-03
0
9.5
2026-04
3
5
2026-05
0
8
2026-06
0
3.6
This device (reports/month)Average device in FMZ (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — AirLife Finland Oy