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"3-LEAD,ECG,UNIV,SNAP,18"",INT'L"

Model 0012-00-1503-13 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · DI 06944904028552

MHX — Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) · Class II · 21 CFR 870.1025

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 (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.

61218242019-01: 0 reports for this device; peer average 8.07/device2019-02: 0 reports for this device; peer average 2.73/device2019-03: 0 reports for this device; peer average 4/device2019-04: 0 reports for this device; peer average 3.67/device2019-05: 0 reports for this device; peer average 5.74/device2019-06: 0 reports for this device; peer average 4.87/device2019-07: 0 reports for this device; peer average 7.26/device2019-08: 0 reports for this device; peer average 6.92/device2019-09: 0 reports for this device; peer average 6.77/device2019-10: 0 reports for this device; peer average 8.24/device2019-11: 0 reports for this device; peer average 9.4/device2019-12: 0 reports for this device; peer average 6.33/device2020-01: 0 reports for this device; peer average 5.84/device2020-02: 0 reports for this device; peer average 7.47/device2020-03: 0 reports for this device; peer average 5.73/device2020-04: 0 reports for this device; peer average 6.16/device2020-05: 0 reports for this device; peer average 4.85/device2020-06: 0 reports for this device; peer average 6.05/device2020-07: 0 reports for this device; peer average 7.95/device2020-08: 0 reports for this device; peer average 6.22/device2020-09: 0 reports for this device; peer average 7.08/device2020-10: 0 reports for this device; peer average 5.39/device2020-11: 0 reports for this device; peer average 9.22/device2020-12: 0 reports for this device; peer average 9.6/device2021-01: 0 reports for this device; peer average 6.13/device2021-02: 0 reports for this device; peer average 10.29/device2021-03: 0 reports for this device; peer average 14.31/device2021-04: 0 reports for this device; peer average 18.59/device2021-05: 0 reports for this device; peer average 11.03/device2021-06: 0 reports for this device; peer average 12.86/device2021-07: 0 reports for this device; peer average 15.92/device2021-08: 0 reports for this device; peer average 18.12/device2021-09: 0 reports for this device; peer average 12.52/device2021-10: 0 reports for this device; peer average 12.73/device2021-11: 0 reports for this device; peer average 11.77/device2021-12: 0 reports for this device; peer average 13.28/device2022-01: 0 reports for this device; peer average 8.79/device2022-02: 0 reports for this device; peer average 9.71/device2022-03: 0 reports for this device; peer average 9.32/device2022-04: 0 reports for this device; peer average 7.18/device2022-05: 0 reports for this device; peer average 9.26/device2022-06: 0 reports for this device; peer average 5/device2022-07: 0 reports for this device; peer average 8.5/device2022-08: 0 reports for this device; peer average 8.4/device2022-09: 0 reports for this device; peer average 4.08/device2022-10: 0 reports for this device; peer average 4.85/device2022-11: 0 reports for this device; peer average 6.86/device2022-12: 0 reports for this device; peer average 6.34/device2023-01: 0 reports for this device; peer average 6.31/device2023-02: 0 reports for this device; peer average 7.55/device2023-03: 0 reports for this device; peer average 16.15/device2023-04: 0 reports for this device; peer average 11.67/device2023-05: 0 reports for this device; peer average 11.62/device2023-06: 0 reports for this device; peer average 10.37/device2023-07: 0 reports for this device; peer average 9.83/device2023-08: 0 reports for this device; peer average 9.53/device2023-09: 0 reports for this device; peer average 14.33/device2023-10: 0 reports for this device; peer average 10.53/device2023-11: 0 reports for this device; peer average 7.92/device2023-12: 0 reports for this device; peer average 12.07/device2024-01: 0 reports for this device; peer average 8.63/device2024-02: 0 reports for this device; peer average 11.08/device2024-03: 0 reports for this device; peer average 12.58/device2024-04: 0 reports for this device; peer average 9.02/device2024-05: 0 reports for this device; peer average 10.2/device2024-06: 0 reports for this device; peer average 9.88/device2024-07: 0 reports for this device; peer average 8.36/device2024-08: 0 reports for this device; peer average 11.2/device2024-09: 0 reports for this device; peer average 9.38/device2024-10: 0 reports for this device; peer average 12.55/device2024-11: 0 reports for this device; peer average 11.68/device2024-12: 0 reports for this device; peer average 10.27/device2025-01: 0 reports for this device; peer average 12.54/device2025-02: 0 reports for this device; peer average 11.46/device2025-03: 0 reports for this device; peer average 16.37/device2025-04: 0 reports for this device; peer average 13/device2025-05: 0 reports for this device; peer average 13.62/device2025-06: 0 reports for this device; peer average 16.23/device2025-07: 0 reports for this device; peer average 18.92/device2025-08: 0 reports for this device; peer average 13.56/device2025-09: 0 reports for this device; peer average 13.69/device2025-10: 0 reports for this device; peer average 22.11/device2025-11: 0 reports for this device; peer average 15.64/device2025-12: 0 reports for this device; peer average 18.23/device2026-01: 0 reports for this device; peer average 17.16/device2026-02: 0 reports for this device; peer average 22.52/device2026-03: 0 reports for this device; peer average 22.05/device2026-04: 0 reports for this device; peer average 19.73/device2026-05: 0 reports for this device; peer average 23.7/device2026-06: 0 reports for this device; peer average 21.32/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0108.07
2019-0202.73
2019-0304
2019-0403.67
2019-0505.74
2019-0604.87
2019-0707.26
2019-0806.92
2019-0906.77
2019-1008.24
2019-1109.4
2019-1206.33
2020-0105.84
2020-0207.47
2020-0305.73
2020-0406.16
2020-0504.85
2020-0606.05
2020-0707.95
2020-0806.22
2020-0907.08
2020-1005.39
2020-1109.22
2020-1209.6
2021-0106.13
2021-02010.29
2021-03014.31
2021-04018.59
2021-05011.03
2021-06012.86
2021-07015.92
2021-08018.12
2021-09012.52
2021-10012.73
2021-11011.77
2021-12013.28
2022-0108.79
2022-0209.71
2022-0309.32
2022-0407.18
2022-0509.26
2022-0605
2022-0708.5
2022-0808.4
2022-0904.08
2022-1004.85
2022-1106.86
2022-1206.34
2023-0106.31
2023-0207.55
2023-03016.15
2023-04011.67
2023-05011.62
2023-06010.37
2023-0709.83
2023-0809.53
2023-09014.33
2023-10010.53
2023-1107.92
2023-12012.07
2024-0108.63
2024-02011.08
2024-03012.58
2024-0409.02
2024-05010.2
2024-0609.88
2024-0708.36
2024-08011.2
2024-0909.38
2024-10012.55
2024-11011.68
2024-12010.27
2025-01012.54
2025-02011.46
2025-03016.37
2025-04013
2025-05013.62
2025-06016.23
2025-07018.92
2025-08013.56
2025-09013.69
2025-10022.11
2025-11015.64
2025-12018.23
2026-01017.16
2026-02022.52
2026-03022.05
2026-04019.73
2026-05023.7
2026-06021.32
This device (reports/month)Average device in MHX (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K143195 — cites (transitively): K092449 (d1), K123074 (d1), K132026 (d1), K132037 (d1), K132075 (d1), K072235 (d2), K091786 (d2), K102562 (d2), K021778 (d3), K030038 (d3), K032858 (d3), K033444 (d3), K041235 (d3), K050762 (d3), K053522 (d3), K082633 (d3), K100939 (d3) — cited as predicate by K150082, K150352, K150632, K152902

Lineage extracted from public 510(k) summary text (heuristic).

Manufacturer compliance record — Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

  • NAI 2017-04-14 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 0 citations
  • VAI 2017-04-14 SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. · 0 citations
  • VAI 2017-04-14 SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. · 0 citations
  • NAI 2017-04-14 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 0 citations
  • VAI 2015-05-15 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 1 citations
  • VAI 2012-04-12 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 5 citations