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15 mm Adaptor
Model 321157 · Boston Medical Products, Inc. · DI EBES3211570
BTR — Tube, Tracheal (W/Wo Connector) · Class II · 21 CFR 868.5730
UDILibrary device dossier · generated 2026-09-06 · 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
1.62
2019-02
0
2.28
2019-03
0
2.18
2019-04
0
2.81
2019-05
0
2.39
2019-06
0
2.29
2019-07
0
2.68
2019-08
0
1.86
2019-09
0
4.33
2019-10
0
2.48
2019-11
0
2.17
2019-12
0
1.76
2020-01
0
2.19
2020-02
0
2.11
2020-03
0
1.74
2020-04
0
2.08
2020-05
0
3.56
2020-06
0
2.73
2020-07
0
2.66
2020-08
0
2.54
2020-09
0
2.03
2020-10
0
2.42
2020-11
0
2.63
2020-12
0
1.85
2021-01
0
2.43
2021-02
0
2.5
2021-03
0
2.21
2021-04
0
2.68
2021-05
0
2.46
2021-06
0
3.44
2021-07
0
2.83
2021-08
0
2.6
2021-09
0
2.25
2021-10
0
2.43
2021-11
0
2.61
2021-12
0
1.88
2022-01
0
1.86
2022-02
0
1.83
2022-03
0
1.86
2022-04
0
2.36
2022-05
0
2.64
2022-06
0
2.56
2022-07
0
1.95
2022-08
0
2.04
2022-09
0
2.28
2022-10
0
2.19
2022-11
0
2.11
2022-12
0
2.86
2023-01
0
2.43
2023-02
0
2.43
2023-03
0
2.4
2023-04
0
2.02
2023-05
0
2.93
2023-06
0
2.68
2023-07
0
2.46
2023-08
0
2.52
2023-09
0
2.6
2023-10
0
2.28
2023-11
0
2.45
2023-12
0
2.02
2024-01
0
2.35
2024-02
0
2.28
2024-03
0
2.45
2024-04
0
2.13
2024-05
0
2.23
2024-06
0
2.26
2024-07
0
2.33
2024-08
0
3.17
2024-09
0
2.9
2024-10
0
2.72
2024-11
0
2.46
2024-12
0
2.04
2025-01
0
3.1
2025-02
0
2.02
2025-03
0
2.88
2025-04
0
2.65
2025-05
0
3.24
2025-06
0
2.59
2025-07
0
2.47
2025-08
0
2.38
2025-09
0
2.48
2025-10
0
3.52
2025-11
0
2.08
2025-12
0
2.94
2026-01
0
2.85
2026-02
0
1.94
2026-03
0
3.41
2026-04
0
2.02
2026-05
0
2.33
2026-06
0
2.37
This device (reports/month)Average device in BTR (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — Boston Medical Products, Inc.
NAI 2013-03-20 Boston Medical Products, Inc. · 0 citations
NAI 2013-03-20 Boston Medical Products, Inc. · 0 citations