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2-Slot AG/O2/BIS Module
Model 115-056532-00 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · DI 06936415919115
BSZ — Gas-Machine, Anesthesia · Class II · 21 CFR 868.5160
UDILibrary device dossier · generated 2026-09-13 · 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
2.5
2019-02
0
4.67
2019-03
0
4.5
2019-04
0
7.08
2019-05
0
3.75
2019-06
0
2.8
2019-07
0
7.5
2019-08
0
2.5
2019-09
0
15.7
2019-10
0
9.18
2019-11
0
5.11
2019-12
0
8.57
2020-01
0
5.14
2020-02
0
5
2020-03
0
7.86
2020-04
0
5.8
2020-05
0
3
2020-06
0
2.57
2020-07
0
5.13
2020-08
0
6.71
2020-09
0
6.83
2020-10
0
5.78
2020-11
0
6.86
2020-12
0
6.88
2021-01
0
7.14
2021-02
0
5
2021-03
0
10.57
2021-04
0
8.71
2021-05
0
5.71
2021-06
0
6.11
2021-07
0
3.71
2021-08
0
7
2021-09
0
6
2021-10
0
6.83
2021-11
0
6.83
2021-12
0
6.3
2022-01
0
4.57
2022-02
0
4.86
2022-03
0
9.57
2022-04
0
8.11
2022-05
0
8.38
2022-06
0
23.4
2022-07
0
16.14
2022-08
0
13
2022-09
0
16.57
2022-10
0
12.63
2022-11
0
10.88
2022-12
0
9.27
2023-01
0
9
2023-02
0
12.5
2023-03
0
7.86
2023-04
0
7.9
2023-05
0
8.58
2023-06
0
11.89
2023-07
0
9.67
2023-08
0
10.55
2023-09
0
14.3
2023-10
0
21.35
2023-11
0
19.22
2023-12
0
22.15
2024-01
0
9.08
2024-02
0
10.15
2024-03
0
18.25
2024-04
0
20.53
2024-05
0
19.28
2024-06
0
20.83
2024-07
0
20.3
2024-08
0
22.25
2024-09
0
21.04
2024-10
0
25.22
2024-11
0
26.25
2024-12
0
21.05
2025-01
0
23.68
2025-02
0
19.05
2025-03
0
28.65
2025-04
0
48.27
2025-05
0
69.36
2025-06
0
56.35
2025-07
0
48.93
2025-08
0
35.75
2025-09
0
33.3
2025-10
0
34.56
2025-11
0
33.71
2025-12
0
48.9
2026-01
0
35.25
2026-02
0
54.15
2026-03
0
38.83
2026-04
0
49.1
2026-05
0
46.68
2026-06
0
38.65
This device (reports/month)Average device in BSZ (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Predicate lineage
K182075 — cited as predicate by K182667, K190011, K191769, K192514, K192584, K192972, K211475, K232962, K251160
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — Shenzhen Mindray Bio-Medical Electronics Co., Ltd.