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Philips

Model A0004D03 · APK Technology Co.,Ltd. · DI 06946725527153

DSA — Cable, Transducer And Electrode, Patient, (Including Connector) · Class II · 21 CFR 870.2900

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.

23572019-04: 0 reports for this device; peer average 2/device2019-05: 0 reports for this device; peer average 1.67/device2019-06: 0 reports for this device; peer average 1.33/device2019-07: 0 reports for this device; peer average 1.33/device2019-08: 0 reports for this device; peer average 2/device2019-09: 0 reports for this device; peer average 1/device2019-10: 0 reports for this device; peer average 1.5/device2019-12: 0 reports for this device; peer average 1.5/device2020-01: 0 reports for this device; peer average 1/device2020-02: 0 reports for this device; peer average 1/device2020-06: 0 reports for this device; peer average 6/device2020-07: 0 reports for this device; peer average 1.67/device2020-08: 0 reports for this device; peer average 6/device2020-09: 0 reports for this device; peer average 2/device2020-10: 0 reports for this device; peer average 5/device2020-11: 0 reports for this device; peer average 1/device2020-12: 0 reports for this device; peer average 1/device2021-01: 0 reports for this device; peer average 1/device2021-02: 0 reports for this device; peer average 1.33/device2021-03: 0 reports for this device; peer average 1.5/device2021-04: 0 reports for this device; peer average 1.5/device2021-05: 0 reports for this device; peer average 1/device2021-06: 0 reports for this device; peer average 1.5/device2021-07: 0 reports for this device; peer average 1.33/device2021-08: 0 reports for this device; peer average 1/device2021-09: 0 reports for this device; peer average 2.25/device2021-10: 0 reports for this device; peer average 1.8/device2021-11: 0 reports for this device; peer average 2.5/device2021-12: 0 reports for this device; peer average 1/device2022-01: 0 reports for this device; peer average 1.25/device2022-02: 0 reports for this device; peer average 1/device2022-03: 0 reports for this device; peer average 1.8/device2022-04: 0 reports for this device; peer average 3/device2022-05: 0 reports for this device; peer average 2/device2022-06: 0 reports for this device; peer average 2.86/device2022-07: 0 reports for this device; peer average 2.63/device2022-08: 0 reports for this device; peer average 2/device2022-09: 0 reports for this device; peer average 1.2/device2022-10: 0 reports for this device; peer average 1.67/device2022-11: 0 reports for this device; peer average 2.25/device2022-12: 0 reports for this device; peer average 1.4/device2023-01: 0 reports for this device; peer average 1.2/device2023-02: 0 reports for this device; peer average 1/device2023-03: 0 reports for this device; peer average 1.43/device2023-04: 0 reports for this device; peer average 1.5/device2023-05: 0 reports for this device; peer average 1.25/device2023-06: 0 reports for this device; peer average 1.8/device2023-07: 0 reports for this device; peer average 1.33/device2023-08: 0 reports for this device; peer average 1.22/device2023-09: 0 reports for this device; peer average 1.25/device2023-10: 0 reports for this device; peer average 1.4/device2023-11: 0 reports for this device; peer average 1.5/device2023-12: 0 reports for this device; peer average 1/device2024-01: 0 reports for this device; peer average 1.6/device2024-02: 0 reports for this device; peer average 1.14/device2024-03: 0 reports for this device; peer average 1/device2024-04: 0 reports for this device; peer average 2/device2024-05: 0 reports for this device; peer average 5.67/device2024-06: 0 reports for this device; peer average 2.5/device2024-07: 0 reports for this device; peer average 2.75/device2024-08: 0 reports for this device; peer average 6.5/device2024-09: 0 reports for this device; peer average 2/device2024-10: 0 reports for this device; peer average 1.8/device2024-11: 0 reports for this device; peer average 1.5/device2024-12: 0 reports for this device; peer average 4.17/device2025-01: 0 reports for this device; peer average 1.75/device2025-02: 0 reports for this device; peer average 3.2/device2025-03: 0 reports for this device; peer average 2.5/device2025-04: 0 reports for this device; peer average 1.5/device2025-05: 0 reports for this device; peer average 6.6/device2025-06: 0 reports for this device; peer average 3.25/device2025-07: 0 reports for this device; peer average 1.57/device2025-08: 0 reports for this device; peer average 2.5/device2025-09: 0 reports for this device; peer average 2/device2025-10: 0 reports for this device; peer average 2.38/device2025-11: 0 reports for this device; peer average 2.67/device2025-12: 0 reports for this device; peer average 2.38/device2026-01: 0 reports for this device; peer average 1.71/device2026-02: 0 reports for this device; peer average 5.67/device2026-03: 0 reports for this device; peer average 3.13/device2026-04: 0 reports for this device; peer average 3.43/device2026-05: 0 reports for this device; peer average 3.22/device2026-06: 0 reports for this device; peer average 3.75/device0405060708091012010206070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0402
2019-0501.67
2019-0601.33
2019-0701.33
2019-0802
2019-0901
2019-1001.5
2019-1201.5
2020-0101
2020-0201
2020-0606
2020-0701.67
2020-0806
2020-0902
2020-1005
2020-1101
2020-1201
2021-0101
2021-0201.33
2021-0301.5
2021-0401.5
2021-0501
2021-0601.5
2021-0701.33
2021-0801
2021-0902.25
2021-1001.8
2021-1102.5
2021-1201
2022-0101.25
2022-0201
2022-0301.8
2022-0403
2022-0502
2022-0602.86
2022-0702.63
2022-0802
2022-0901.2
2022-1001.67
2022-1102.25
2022-1201.4
2023-0101.2
2023-0201
2023-0301.43
2023-0401.5
2023-0501.25
2023-0601.8
2023-0701.33
2023-0801.22
2023-0901.25
2023-1001.4
2023-1101.5
2023-1201
2024-0101.6
2024-0201.14
2024-0301
2024-0402
2024-0505.67
2024-0602.5
2024-0702.75
2024-0806.5
2024-0902
2024-1001.8
2024-1101.5
2024-1204.17
2025-0101.75
2025-0203.2
2025-0302.5
2025-0401.5
2025-0506.6
2025-0603.25
2025-0701.57
2025-0802.5
2025-0902
2025-1002.38
2025-1102.67
2025-1202.38
2026-0101.71
2026-0205.67
2026-0303.13
2026-0403.43
2026-0503.22
2026-0603.75
This device (reports/month)Average device in DSA (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K170536 — cites (transitively): K120010 (d1), K082959 (d2), K992524 (d2) — cited as predicate by K181089, K211941

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

Manufacturer compliance record — APK Technology Co.,Ltd.

  • Warning Letter 2015-08-06 APK Technology Co., Ltd.
  • Warning Letter 2015-08-06 APK Technology Co., Ltd.
  • NAI 2023-12-14 APK Technology Co., Ltd. · 0 citations
  • NAI 2023-12-14 APK Technology Co., Ltd. · 0 citations
  • VAI 2019-10-24 APK Technology Co., Ltd. · 0 citations
  • VAI 2019-10-24 APK Technology Co., Ltd. · 0 citations
  • VAI 2016-04-14 APK Technology Co., Ltd. · 3 citations
  • VAI 2016-04-14 APK Technology Co., Ltd. · 3 citations
  • OAI 2015-02-03 APK Technology Co., Ltd. · 0 citations
  • OAI 2015-02-03 APK Technology Co., Ltd. · 0 citations