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APEX

Model WiZARD 310 · Wellell Inc. · DI 04713025000776

BZD — Ventilator, Non-Continuous (Respirator) · Class II · 21 CFR 868.5905

UDILibrary device dossier · generated 2026-09-07 · 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.

40801211612019-01: 0 reports for this device; peer average 2.67/device2019-02: 0 reports for this device; peer average 1.33/device2019-03: 0 reports for this device; peer average 1.25/device2019-04: 0 reports for this device; peer average 1.88/device2019-05: 0 reports for this device; peer average 1.91/device2019-06: 0 reports for this device; peer average 1.33/device2019-07: 0 reports for this device; peer average 2.43/device2019-08: 0 reports for this device; peer average 1.33/device2019-09: 0 reports for this device; peer average 1.2/device2019-10: 0 reports for this device; peer average 1.4/device2019-11: 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 1.55/device2020-02: 0 reports for this device; peer average 2.17/device2020-03: 0 reports for this device; peer average 1.6/device2020-04: 0 reports for this device; peer average 1.5/device2020-05: 0 reports for this device; peer average 2/device2020-06: 0 reports for this device; peer average 2/device2020-07: 0 reports for this device; peer average 1.33/device2020-08: 0 reports for this device; peer average 2.33/device2020-09: 0 reports for this device; peer average 1.25/device2020-10: 0 reports for this device; peer average 1.67/device2020-11: 0 reports for this device; peer average 1/device2020-12: 0 reports for this device; peer average 1.83/device2021-02: 0 reports for this device; peer average 2/device2021-03: 0 reports for this device; peer average 2.2/device2021-04: 0 reports for this device; peer average 2/device2021-05: 0 reports for this device; peer average 4.81/device2021-06: 0 reports for this device; peer average 3.63/device2021-07: 0 reports for this device; peer average 4.64/device2021-08: 0 reports for this device; peer average 8.99/device2021-09: 0 reports for this device; peer average 8.19/device2021-10: 0 reports for this device; peer average 10.43/device2021-11: 0 reports for this device; peer average 10.12/device2021-12: 0 reports for this device; peer average 11.27/device2022-01: 0 reports for this device; peer average 23.23/device2022-02: 0 reports for this device; peer average 27.05/device2022-03: 0 reports for this device; peer average 25.55/device2022-04: 0 reports for this device; peer average 31.16/device2022-05: 0 reports for this device; peer average 78.89/device2022-06: 0 reports for this device; peer average 147.93/device2022-07: 0 reports for this device; peer average 132.07/device2022-08: 0 reports for this device; peer average 68.39/device2022-09: 0 reports for this device; peer average 54.34/device2022-10: 0 reports for this device; peer average 31.75/device2022-11: 0 reports for this device; peer average 34.73/device2022-12: 0 reports for this device; peer average 24.59/device2023-01: 0 reports for this device; peer average 30.93/device2023-02: 0 reports for this device; peer average 19.79/device2023-03: 0 reports for this device; peer average 12.85/device2023-04: 0 reports for this device; peer average 14.27/device2023-05: 0 reports for this device; peer average 19.74/device2023-06: 0 reports for this device; peer average 13.85/device2023-07: 0 reports for this device; peer average 16.64/device2023-08: 0 reports for this device; peer average 19.74/device2023-09: 0 reports for this device; peer average 15.97/device2023-10: 0 reports for this device; peer average 14.69/device2023-11: 0 reports for this device; peer average 22.58/device2023-12: 0 reports for this device; peer average 34.64/device2024-01: 0 reports for this device; peer average 30.64/device2024-02: 0 reports for this device; peer average 31.69/device2024-03: 0 reports for this device; peer average 34.06/device2024-04: 0 reports for this device; peer average 47.2/device2024-05: 0 reports for this device; peer average 54.67/device2024-06: 0 reports for this device; peer average 50.79/device2024-07: 0 reports for this device; peer average 45.23/device2024-08: 0 reports for this device; peer average 63.06/device2024-09: 0 reports for this device; peer average 54.2/device2024-10: 0 reports for this device; peer average 66.51/device2024-11: 0 reports for this device; peer average 49.45/device2024-12: 0 reports for this device; peer average 29.62/device2025-01: 0 reports for this device; peer average 38.98/device2025-02: 0 reports for this device; peer average 160.13/device2025-03: 0 reports for this device; peer average 160.72/device2025-04: 0 reports for this device; peer average 39.32/device2025-05: 0 reports for this device; peer average 14.4/device2025-06: 0 reports for this device; peer average 18.39/device2025-07: 0 reports for this device; peer average 13.98/device2025-08: 0 reports for this device; peer average 6.77/device2025-09: 0 reports for this device; peer average 8.36/device2025-10: 0 reports for this device; peer average 8.59/device2025-11: 0 reports for this device; peer average 98.48/device2025-12: 0 reports for this device; peer average 9.14/device2026-01: 0 reports for this device; peer average 23.24/device2026-02: 0 reports for this device; peer average 44.59/device2026-03: 0 reports for this device; peer average 42.56/device2026-04: 0 reports for this device; peer average 7.62/device2026-05: 0 reports for this device; peer average 100/device2026-06: 0 reports for this device; peer average 145.14/device0102030405060708091011120102030405060708091011120203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102.67
2019-0201.33
2019-0301.25
2019-0401.88
2019-0501.91
2019-0601.33
2019-0702.43
2019-0801.33
2019-0901.2
2019-1001.4
2019-1101.5
2019-1201.5
2020-0101.55
2020-0202.17
2020-0301.6
2020-0401.5
2020-0502
2020-0602
2020-0701.33
2020-0802.33
2020-0901.25
2020-1001.67
2020-1101
2020-1201.83
2021-0202
2021-0302.2
2021-0402
2021-0504.81
2021-0603.63
2021-0704.64
2021-0808.99
2021-0908.19
2021-10010.43
2021-11010.12
2021-12011.27
2022-01023.23
2022-02027.05
2022-03025.55
2022-04031.16
2022-05078.89
2022-060147.93
2022-070132.07
2022-08068.39
2022-09054.34
2022-10031.75
2022-11034.73
2022-12024.59
2023-01030.93
2023-02019.79
2023-03012.85
2023-04014.27
2023-05019.74
2023-06013.85
2023-07016.64
2023-08019.74
2023-09015.97
2023-10014.69
2023-11022.58
2023-12034.64
2024-01030.64
2024-02031.69
2024-03034.06
2024-04047.2
2024-05054.67
2024-06050.79
2024-07045.23
2024-08063.06
2024-09054.2
2024-10066.51
2024-11049.45
2024-12029.62
2025-01038.98
2025-020160.13
2025-030160.72
2025-04039.32
2025-05014.4
2025-06018.39
2025-07013.98
2025-0806.77
2025-0908.36
2025-1008.59
2025-11098.48
2025-1209.14
2026-01023.24
2026-02044.59
2026-03042.56
2026-0407.62
2026-050100
2026-060145.14
This device (reports/month)Average device in BZD (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K182394 — cites (transitively): K103174 (d1), K170924 (d1), K171212 (d1), K000705 (d2), K002465 (d2), K961915 (d2), K991648 (d2), K153563 (d2), K161978 (d2), K123979 (d3), K132887 (d3), K031047 (d3), K032433 (d3), K132013 (d3), K153673 (d3), K063122 (d4), K050359 (d4), K060359 (d4), K090244 (d4), K060273 (d4), K123789 (d4) — cited as predicate by K193206, K243023

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

Manufacturer compliance record — Wellell Inc.

  • NAI 2015-02-04 Apex Medical (Kunshan) Corp. · 2 citations
  • VAI 2014-11-07 Wellell Inc · 0 citations
  • VAI 2014-11-07 Wellell Inc · 0 citations
  • VAI 2012-02-23 Wellell Inc · 2 citations
  • VAI 2012-02-23 Wellell Inc · 2 citations
  • NAI 2011-12-01 Apex Medical (Kunshan) Corp. · 0 citations