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"Adult Single Heated Wire Breathing System 1.6M (63"") (Kit 2)"
Model 038-31-102U · FLEXICARE MEDICAL LIMITED · DI 05055788708681
BTT — Humidifier, Respiratory Gas, (Direct Patient Interface) · Class II · 21 CFR 868.5450
BZE — Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer · Class II · 21 CFR 868.5270
UDILibrary device dossier · generated 2026-09-11 · 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
6.6
2019-02
0
4.18
2019-03
0
8.8
2019-04
0
4.5
2019-05
0
2.88
2019-06
0
6.83
2019-07
0
4.18
2019-08
0
3.76
2019-09
0
3.33
2019-10
0
5.9
2019-11
0
7.44
2019-12
0
3.73
2020-01
0
4.63
2020-02
0
2.56
2020-03
0
2
2020-04
0
3
2020-05
0
1.67
2020-06
0
1.43
2020-07
0
1.86
2020-08
0
1.89
2020-09
0
1.44
2020-10
0
1.86
2020-11
0
2.89
2020-12
0
2.64
2021-01
0
2.42
2021-02
0
5.14
2021-03
0
10.69
2021-04
0
4.63
2021-05
0
5.62
2021-06
0
5.67
2021-07
0
4
2021-08
0
12.08
2021-09
0
10.72
2021-10
0
12.8
2021-11
0
9.15
2021-12
0
9.71
2022-01
0
6.52
2022-02
0
6.73
2022-03
0
18.6
2022-04
0
6.73
2022-05
0
6.43
2022-06
0
8.55
2022-07
0
5.04
2022-08
0
5.62
2022-09
0
6.09
2022-10
0
6.5
2022-11
0
5.29
2022-12
0
6.33
2023-01
0
6.47
2023-02
0
10.16
2023-03
0
11.2
2023-04
0
7.67
2023-05
0
5.97
2023-06
0
7.8
2023-07
0
5.84
2023-08
0
9.13
2023-09
0
7.18
2023-10
0
9.27
2023-11
0
13.19
2023-12
0
6.96
2024-01
0
18.7
2024-02
0
12.72
2024-03
0
12.61
2024-04
0
9.61
2024-05
0
9.14
2024-06
0
7.49
2024-07
0
8.51
2024-08
0
11.03
2024-09
0
9.35
2024-10
0
13.88
2024-11
0
17.76
2024-12
0
11.77
2025-01
0
12.38
2025-02
0
5.03
2025-03
0
13.33
2025-04
0
15
2025-05
0
10.21
2025-06
0
13.68
2025-07
0
13.19
2025-08
0
9.44
2025-09
0
9
2025-10
0
13.22
2025-11
0
32.49
2025-12
0
17.13
2026-01
0
12.73
2026-02
0
13.9
2026-03
0
20.67
2026-04
0
21.31
2026-05
0
15.74
2026-06
0
10.57
This device (reports/month)Average device in BTT, BZE (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — FLEXICARE MEDICAL LIMITED
VAI 2024-05-09 FLEXICARE LANKA (PVT) LTD · 3 citations
VAI 2024-03-21 Flexicare Medical (Dongguan) Ltd. · 3 citations
VAI 2016-10-13 CLEMENT CLARKE INTL., LTD. · 5 citations
NAI 2013-01-24 Flexicare Medical (Dongguan) Ltd. · 0 citations
OAI 2010-08-26 Flexicare Medical (Dongguan) Ltd. · 10 citations