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INSPIRA AIR
Model BC1440A · ACCLARENT, INC. · DI 10705031063310
KTI — Bronchoscope Accessory · Class II · 21 CFR 874.4680
UDILibrary device dossier · generated 2026-09-12 · 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 (4)
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: 4
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-01
1
1
2019-03
0
1.67
2019-04
0
1
2019-05
0
2
2019-06
0
2.5
2019-07
0
4
2019-08
0
14
2019-09
0
2
2019-10
0
2
2019-11
0
2
2019-12
0
1
2020-01
0
3
2020-02
0
1.5
2020-03
0
2
2020-04
0
3.5
2020-06
0
2
2020-07
0
4
2020-08
0
3
2020-09
0
8
2020-10
0
2
2020-12
0
4
2021-01
0
6
2021-02
0
1.67
2021-03
0
2.5
2021-04
0
3
2021-05
0
3
2021-06
3
2.5
2021-07
0
3
2021-08
0
2.25
2021-09
0
3.67
2021-10
0
1
2021-11
0
5
2021-12
0
2
2022-01
0
2.67
2022-03
0
11
2022-04
0
3.33
2022-05
0
6.67
2022-06
0
4.67
2022-07
0
10
2022-08
0
12.67
2022-09
0
9.5
2022-10
0
4.75
2022-11
0
3.5
2022-12
0
3.2
2023-01
0
11
2023-02
0
5
2023-03
0
7.33
2023-04
0
11.75
2023-05
0
9
2023-06
0
2.5
2023-07
0
3
2023-08
0
4
2023-09
0
2
2023-10
0
5.67
2023-11
0
5.83
2023-12
0
5.8
2024-01
0
10
2024-02
0
3.75
2024-03
0
5.33
2024-04
0
4.4
2024-05
0
6.75
2024-06
0
8.5
2024-07
0
9.5
2024-08
0
5
2024-09
0
5
2024-10
0
3.8
2024-11
0
8
2024-12
0
3.5
2025-01
0
4.67
2025-02
0
4
2025-03
0
6.67
2025-04
0
9.5
2025-05
0
3
2025-06
0
8.75
2025-07
0
9.67
2025-08
0
5.6
2025-09
0
5
2025-10
0
7.17
2025-11
0
8.2
2025-12
0
9.17
2026-01
0
7.83
2026-02
0
8.5
2026-03
0
3.5
2026-04
0
4.14
2026-05
0
3.25
2026-06
0
4.5
This device (reports/month)Average device in KTI (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Predicate lineage
K090660 — cited as predicate by K110218, K150951, K153484, K231818
Lineage extracted from public 510(k) summary text (heuristic).