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22MM SMOOTHBORE EXHALATION VALVE HEATED WIRE BREATHING SYSTEM WITH LIMB.1.6M
Model 5194850 · Intersurgical Incorporated · DI 05030267069972
BZE — Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer · Class II · 21 CFR 868.5270
UDILibrary device dossier · generated 2026-09-08 · 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
8
2019-02
0
3.8
2019-03
0
4
2019-04
0
3
2019-05
0
2
2019-06
0
6.33
2019-07
0
3.8
2019-08
0
3
2019-09
0
1.8
2019-10
0
6.43
2019-11
0
8
2019-12
0
2.8
2020-01
0
3.33
2020-02
0
1.5
2020-03
0
1.5
2020-04
0
2.25
2020-05
0
1.33
2020-06
0
1
2020-07
0
1.5
2020-08
0
1.67
2020-09
0
1
2020-10
0
2.5
2020-11
0
2.8
2020-12
0
2.5
2021-01
0
2
2021-02
0
1.4
2021-03
0
1.8
2021-04
0
2
2021-05
0
3.2
2021-06
0
3
2021-07
0
3
2021-08
0
16.45
2021-09
0
17.36
2021-10
0
19.64
2021-11
0
9.44
2021-12
0
9.6
2022-01
0
7.82
2022-02
0
4.6
2022-03
0
35.18
2022-04
0
10.46
2022-05
0
9.38
2022-06
0
13.38
2022-07
0
6.56
2022-08
0
6.25
2022-09
0
10.38
2022-10
0
9.45
2022-11
0
8.82
2022-12
0
9
2023-01
0
8.88
2023-02
0
18.25
2023-03
0
17.58
2023-04
0
9.5
2023-05
0
8.44
2023-06
0
8
2023-07
0
6.44
2023-08
0
16.13
2023-09
0
8.23
2023-10
0
16.27
2023-11
0
21.26
2023-12
0
10
2024-01
0
28.79
2024-02
0
18.2
2024-03
0
18.37
2024-04
0
14.41
2024-05
0
14.95
2024-06
0
11.05
2024-07
0
12.18
2024-08
0
15.41
2024-09
0
16.94
2024-10
0
29.31
2024-11
0
28.5
2024-12
0
17.1
2025-01
0
23.41
2025-02
0
5.56
2025-03
0
20.33
2025-04
0
23.4
2025-05
0
14.71
2025-06
0
25.06
2025-07
0
23.83
2025-08
0
13.4
2025-09
0
13.18
2025-10
0
11.68
2025-11
0
35.06
2025-12
0
10.41
2026-01
0
8
2026-02
0
12.39
2026-03
0
21.33
2026-04
0
20.29
2026-05
0
17.35
2026-06
0
11.1
This device (reports/month)Average device in BZE (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — Intersurgical Incorporated