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Triple Transducer Connect

Model P16535-52R · FUJIFILM SONOSITE, INC. · DI 00841517110352

ITX — Transducer, Ultrasonic, Diagnostic · Class II · 21 CFR 892.1570

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

IYO — System, Imaging, Pulsed Echo, Ultrasonic · Class II · 21 CFR 892.1560

UDILibrary device dossier · generated 2026-09-16 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (1)

InitiatedRecall #ClassStatusReasonLink basis
2013-09-11Z-0027-2014Class IITerminatedFUJIFILM SonoSite Inc. remove P21x/5-1 Transducer because the firm discovered the Biopsy Bracket Sensor is not working as intended.k number procode

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.

5914192019-01: 0 reports for this device; peer average 3.15/device2019-02: 0 reports for this device; peer average 5.46/device2019-03: 0 reports for this device; peer average 5.81/device2019-04: 0 reports for this device; peer average 3.3/device2019-05: 0 reports for this device; peer average 5.27/device2019-06: 0 reports for this device; peer average 6.28/device2019-07: 0 reports for this device; peer average 5.59/device2019-08: 0 reports for this device; peer average 7.45/device2019-09: 0 reports for this device; peer average 3.92/device2019-10: 0 reports for this device; peer average 3.57/device2019-11: 0 reports for this device; peer average 4.04/device2019-12: 0 reports for this device; peer average 4.84/device2020-01: 0 reports for this device; peer average 2.75/device2020-02: 0 reports for this device; peer average 5.41/device2020-03: 0 reports for this device; peer average 5.5/device2020-04: 0 reports for this device; peer average 5.17/device2020-05: 0 reports for this device; peer average 2.89/device2020-06: 0 reports for this device; peer average 3.16/device2020-07: 0 reports for this device; peer average 4.32/device2020-08: 0 reports for this device; peer average 2.93/device2020-09: 0 reports for this device; peer average 2.07/device2020-10: 0 reports for this device; peer average 3.79/device2020-11: 0 reports for this device; peer average 4.01/device2020-12: 0 reports for this device; peer average 5.87/device2021-01: 0 reports for this device; peer average 6.53/device2021-02: 0 reports for this device; peer average 4.61/device2021-03: 0 reports for this device; peer average 7.44/device2021-04: 0 reports for this device; peer average 4.17/device2021-05: 0 reports for this device; peer average 5.98/device2021-06: 0 reports for this device; peer average 6.44/device2021-07: 0 reports for this device; peer average 8.34/device2021-08: 0 reports for this device; peer average 7.22/device2021-09: 0 reports for this device; peer average 9.35/device2021-10: 0 reports for this device; peer average 5.7/device2021-11: 0 reports for this device; peer average 6.88/device2021-12: 0 reports for this device; peer average 9.64/device2022-01: 0 reports for this device; peer average 6.49/device2022-02: 0 reports for this device; peer average 8.37/device2022-03: 0 reports for this device; peer average 7.24/device2022-04: 0 reports for this device; peer average 8.11/device2022-05: 0 reports for this device; peer average 9.67/device2022-06: 0 reports for this device; peer average 7.56/device2022-07: 0 reports for this device; peer average 7.46/device2022-08: 0 reports for this device; peer average 5.42/device2022-09: 0 reports for this device; peer average 4.73/device2022-10: 0 reports for this device; peer average 4.62/device2022-11: 0 reports for this device; peer average 4.41/device2022-12: 0 reports for this device; peer average 5.16/device2023-01: 0 reports for this device; peer average 5.01/device2023-02: 0 reports for this device; peer average 4.61/device2023-03: 0 reports for this device; peer average 5.75/device2023-04: 0 reports for this device; peer average 3.78/device2023-05: 0 reports for this device; peer average 6.15/device2023-06: 0 reports for this device; peer average 4.06/device2023-07: 0 reports for this device; peer average 4.25/device2023-08: 0 reports for this device; peer average 5.94/device2023-09: 0 reports for this device; peer average 5.7/device2023-10: 0 reports for this device; peer average 6.69/device2023-11: 0 reports for this device; peer average 5.36/device2023-12: 0 reports for this device; peer average 5.47/device2024-01: 0 reports for this device; peer average 6.28/device2024-02: 0 reports for this device; peer average 4.31/device2024-03: 0 reports for this device; peer average 5.97/device2024-04: 0 reports for this device; peer average 5.86/device2024-05: 0 reports for this device; peer average 4.16/device2024-06: 0 reports for this device; peer average 5.85/device2024-07: 0 reports for this device; peer average 4.97/device2024-08: 0 reports for this device; peer average 5.4/device2024-09: 0 reports for this device; peer average 5.79/device2024-10: 0 reports for this device; peer average 6.4/device2024-11: 0 reports for this device; peer average 4.03/device2024-12: 0 reports for this device; peer average 11.27/device2025-01: 0 reports for this device; peer average 4.34/device2025-02: 0 reports for this device; peer average 4.03/device2025-03: 0 reports for this device; peer average 5.83/device2025-04: 0 reports for this device; peer average 3.25/device2025-05: 0 reports for this device; peer average 3.93/device2025-06: 0 reports for this device; peer average 4.11/device2025-07: 0 reports for this device; peer average 4.1/device2025-08: 0 reports for this device; peer average 5.45/device2025-09: 0 reports for this device; peer average 6.52/device2025-10: 0 reports for this device; peer average 9.71/device2025-11: 0 reports for this device; peer average 12.53/device2025-12: 0 reports for this device; peer average 18.81/device2026-01: 0 reports for this device; peer average 11.99/device2026-02: 0 reports for this device; peer average 6.63/device2026-03: 0 reports for this device; peer average 8.63/device2026-04: 0 reports for this device; peer average 11.88/device2026-05: 0 reports for this device; peer average 16.78/device2026-06: 0 reports for this device; peer average 15.26/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0103.15
2019-0205.46
2019-0305.81
2019-0403.3
2019-0505.27
2019-0606.28
2019-0705.59
2019-0807.45
2019-0903.92
2019-1003.57
2019-1104.04
2019-1204.84
2020-0102.75
2020-0205.41
2020-0305.5
2020-0405.17
2020-0502.89
2020-0603.16
2020-0704.32
2020-0802.93
2020-0902.07
2020-1003.79
2020-1104.01
2020-1205.87
2021-0106.53
2021-0204.61
2021-0307.44
2021-0404.17
2021-0505.98
2021-0606.44
2021-0708.34
2021-0807.22
2021-0909.35
2021-1005.7
2021-1106.88
2021-1209.64
2022-0106.49
2022-0208.37
2022-0307.24
2022-0408.11
2022-0509.67
2022-0607.56
2022-0707.46
2022-0805.42
2022-0904.73
2022-1004.62
2022-1104.41
2022-1205.16
2023-0105.01
2023-0204.61
2023-0305.75
2023-0403.78
2023-0506.15
2023-0604.06
2023-0704.25
2023-0805.94
2023-0905.7
2023-1006.69
2023-1105.36
2023-1205.47
2024-0106.28
2024-0204.31
2024-0305.97
2024-0405.86
2024-0504.16
2024-0605.85
2024-0704.97
2024-0805.4
2024-0905.79
2024-1006.4
2024-1104.03
2024-12011.27
2025-0104.34
2025-0204.03
2025-0305.83
2025-0403.25
2025-0503.93
2025-0604.11
2025-0704.1
2025-0805.45
2025-0906.52
2025-1009.71
2025-11012.53
2025-12018.81
2026-01011.99
2026-0206.63
2026-0308.63
2026-04011.88
2026-05016.78
2026-06015.26
This device (reports/month)Average device in ITX, IYN, IYO (reports/device/month)

Regulatory clearances

  • K113156 SESE 2011-11-15 (k number procode)

Predicate lineage

K113156 — cites (transitively): K071134 (d1), K082098 (d1) — cited as predicate by K130173, K133454, K161168, K161359

K133454 — cites (transitively): K071134 (d1), K082098 (d1), K113156 (d1), K130173 (d1), K101757 (d2), K112953 (d2), K043559 (d3), K092058 (d3), K010883 (d3), K012191 (d3), K030191 (d3), K040840 (d3), K043278 (d3), K080234 (d3), K992505 (d3) — cited as predicate by K142017, K152209, K152983, K153626, K160406, K161119, K162045, K162288, K171437, K172385, K180704

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

Manufacturer compliance record — FUJIFILM SONOSITE, INC.

  • NAI 2012-07-06 FujiFilm SonoSite, Inc. · 0 citations
  • NAI 2010-04-02 FujiFilm SonoSite, Inc. · 0 citations