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UMT-150 Mobile Trolley

Model 045-000630-00 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · DI 06944904085609

IYN — System, Imaging, Pulsed Doppler, Ultrasonic · Class II · 21 CFR 892.1550

UDILibrary device dossier · generated 2026-09-15 · 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.

51116212019-01: 0 reports for this device; peer average 1.8/device2019-02: 0 reports for this device; peer average 2.33/device2019-03: 0 reports for this device; peer average 1.25/device2019-04: 0 reports for this device; peer average 1.71/device2019-05: 0 reports for this device; peer average 2.09/device2019-06: 0 reports for this device; peer average 4.75/device2019-07: 0 reports for this device; peer average 3.43/device2019-08: 0 reports for this device; peer average 2.11/device2019-09: 0 reports for this device; peer average 2.36/device2019-10: 0 reports for this device; peer average 3/device2019-11: 0 reports for this device; peer average 3.79/device2019-12: 0 reports for this device; peer average 3.28/device2020-01: 0 reports for this device; peer average 2.47/device2020-02: 0 reports for this device; peer average 5.8/device2020-03: 0 reports for this device; peer average 3.07/device2020-04: 0 reports for this device; peer average 2.85/device2020-05: 0 reports for this device; peer average 2.31/device2020-06: 0 reports for this device; peer average 2.81/device2020-07: 0 reports for this device; peer average 4.19/device2020-08: 0 reports for this device; peer average 2.75/device2020-09: 0 reports for this device; peer average 2/device2020-10: 0 reports for this device; peer average 3.89/device2020-11: 0 reports for this device; peer average 4.09/device2020-12: 0 reports for this device; peer average 6.5/device2021-01: 0 reports for this device; peer average 7.56/device2021-02: 0 reports for this device; peer average 5.19/device2021-03: 0 reports for this device; peer average 9.81/device2021-04: 0 reports for this device; peer average 4.15/device2021-05: 0 reports for this device; peer average 7.09/device2021-06: 0 reports for this device; peer average 7.08/device2021-07: 0 reports for this device; peer average 10.21/device2021-08: 0 reports for this device; peer average 8.23/device2021-09: 0 reports for this device; peer average 12.85/device2021-10: 0 reports for this device; peer average 5.33/device2021-11: 0 reports for this device; peer average 9.53/device2021-12: 0 reports for this device; peer average 11/device2022-01: 0 reports for this device; peer average 7.11/device2022-02: 0 reports for this device; peer average 9.62/device2022-03: 0 reports for this device; peer average 8.53/device2022-04: 0 reports for this device; peer average 10.86/device2022-05: 0 reports for this device; peer average 13.93/device2022-06: 0 reports for this device; peer average 10.43/device2022-07: 0 reports for this device; peer average 11.23/device2022-08: 0 reports for this device; peer average 5.71/device2022-09: 0 reports for this device; peer average 5.47/device2022-10: 0 reports for this device; peer average 5.33/device2022-11: 0 reports for this device; peer average 5.12/device2022-12: 0 reports for this device; peer average 5.8/device2023-01: 0 reports for this device; peer average 5.05/device2023-02: 0 reports for this device; peer average 5.13/device2023-03: 0 reports for this device; peer average 6.88/device2023-04: 0 reports for this device; peer average 4.38/device2023-05: 0 reports for this device; peer average 8.79/device2023-06: 0 reports for this device; peer average 4.52/device2023-07: 0 reports for this device; peer average 4.86/device2023-08: 0 reports for this device; peer average 8.29/device2023-09: 0 reports for this device; peer average 7/device2023-10: 0 reports for this device; peer average 6.84/device2023-11: 0 reports for this device; peer average 6.52/device2023-12: 0 reports for this device; peer average 6.58/device2024-01: 0 reports for this device; peer average 6.4/device2024-02: 0 reports for this device; peer average 4.27/device2024-03: 0 reports for this device; peer average 7.8/device2024-04: 0 reports for this device; peer average 7.13/device2024-05: 0 reports for this device; peer average 4.53/device2024-06: 0 reports for this device; peer average 6.67/device2024-07: 0 reports for this device; peer average 5.43/device2024-08: 0 reports for this device; peer average 5.41/device2024-09: 0 reports for this device; peer average 7.08/device2024-10: 0 reports for this device; peer average 7.36/device2024-11: 0 reports for this device; peer average 5.04/device2024-12: 0 reports for this device; peer average 13.5/device2025-01: 0 reports for this device; peer average 4.73/device2025-02: 0 reports for this device; peer average 4.39/device2025-03: 0 reports for this device; peer average 6.89/device2025-04: 0 reports for this device; peer average 3.33/device2025-05: 0 reports for this device; peer average 4/device2025-06: 0 reports for this device; peer average 4.19/device2025-07: 0 reports for this device; peer average 4.38/device2025-08: 0 reports for this device; peer average 4.9/device2025-09: 0 reports for this device; peer average 5.62/device2025-10: 0 reports for this device; peer average 10.77/device2025-11: 0 reports for this device; peer average 13.93/device2025-12: 0 reports for this device; peer average 21.04/device2026-01: 0 reports for this device; peer average 12.65/device2026-02: 0 reports for this device; peer average 7.18/device2026-03: 0 reports for this device; peer average 8.91/device2026-04: 0 reports for this device; peer average 13.26/device2026-05: 0 reports for this device; peer average 19.59/device2026-06: 0 reports for this device; peer average 17.26/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101.8
2019-0202.33
2019-0301.25
2019-0401.71
2019-0502.09
2019-0604.75
2019-0703.43
2019-0802.11
2019-0902.36
2019-1003
2019-1103.79
2019-1203.28
2020-0102.47
2020-0205.8
2020-0303.07
2020-0402.85
2020-0502.31
2020-0602.81
2020-0704.19
2020-0802.75
2020-0902
2020-1003.89
2020-1104.09
2020-1206.5
2021-0107.56
2021-0205.19
2021-0309.81
2021-0404.15
2021-0507.09
2021-0607.08
2021-07010.21
2021-0808.23
2021-09012.85
2021-1005.33
2021-1109.53
2021-12011
2022-0107.11
2022-0209.62
2022-0308.53
2022-04010.86
2022-05013.93
2022-06010.43
2022-07011.23
2022-0805.71
2022-0905.47
2022-1005.33
2022-1105.12
2022-1205.8
2023-0105.05
2023-0205.13
2023-0306.88
2023-0404.38
2023-0508.79
2023-0604.52
2023-0704.86
2023-0808.29
2023-0907
2023-1006.84
2023-1106.52
2023-1206.58
2024-0106.4
2024-0204.27
2024-0307.8
2024-0407.13
2024-0504.53
2024-0606.67
2024-0705.43
2024-0805.41
2024-0907.08
2024-1007.36
2024-1105.04
2024-12013.5
2025-0104.73
2025-0204.39
2025-0306.89
2025-0403.33
2025-0504
2025-0604.19
2025-0704.38
2025-0804.9
2025-0905.62
2025-10010.77
2025-11013.93
2025-12021.04
2026-01012.65
2026-0207.18
2026-0308.91
2026-04013.26
2026-05019.59
2026-06017.26
This device (reports/month)Average device in IYN (reports/device/month)

Regulatory clearances

  • K122010 SESE 2012-07-20 (k number procode)

Predicate lineage

K122010 — cites (transitively): K083001 (d1), K090912 (d1), K100830 (d1), K102991 (d1), K103583 (d1), K072797 (d2), K072164 (d2), K032974 (d2), K050240 (d2), K052410 (d2), K060542 (d2), K060993 (d2), K061682 (d2), K101041 (d2) — cited as predicate by K123503, K182603

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