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APEX

Model 9S-005500, 9S-006500 · Wellell Inc. · DI 04713025000028

BTT — Humidifier, Respiratory Gas, (Direct Patient Interface) · Class II · 21 CFR 868.5450

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

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.

35711061412019-01: 0 reports for this device; peer average 3.13/device2019-02: 0 reports for this device; peer average 3.44/device2019-03: 0 reports for this device; peer average 5.63/device2019-04: 0 reports for this device; peer average 3.23/device2019-05: 0 reports for this device; peer average 2.4/device2019-06: 0 reports for this device; peer average 4.33/device2019-07: 0 reports for this device; peer average 3.38/device2019-08: 0 reports for this device; peer average 3.67/device2019-09: 0 reports for this device; peer average 3/device2019-10: 0 reports for this device; peer average 2.63/device2019-11: 0 reports for this device; peer average 5.43/device2019-12: 0 reports for this device; peer average 3.3/device2020-01: 0 reports for this device; peer average 2.62/device2020-02: 0 reports for this device; peer average 3/device2020-03: 0 reports for this device; peer average 2/device2020-04: 0 reports for this device; peer average 2.57/device2020-05: 0 reports for this device; peer average 2/device2020-06: 0 reports for this device; peer average 1.83/device2020-07: 0 reports for this device; peer average 1.75/device2020-08: 0 reports for this device; peer average 2.11/device2020-09: 0 reports for this device; peer average 1.39/device2020-10: 0 reports for this device; peer average 1.63/device2020-11: 0 reports for this device; peer average 2.6/device2020-12: 0 reports for this device; peer average 2.33/device2021-01: 0 reports for this device; peer average 2.45/device2021-02: 0 reports for this device; peer average 5.62/device2021-03: 0 reports for this device; peer average 10.85/device2021-04: 0 reports for this device; peer average 5.13/device2021-05: 0 reports for this device; peer average 5.28/device2021-06: 0 reports for this device; peer average 4.22/device2021-07: 0 reports for this device; peer average 4.6/device2021-08: 0 reports for this device; peer average 8.92/device2021-09: 0 reports for this device; peer average 7.88/device2021-10: 0 reports for this device; peer average 10.06/device2021-11: 0 reports for this device; peer average 10.02/device2021-12: 0 reports for this device; peer average 11.11/device2022-01: 0 reports for this device; peer average 20.79/device2022-02: 0 reports for this device; peer average 25.5/device2022-03: 0 reports for this device; peer average 24.11/device2022-04: 0 reports for this device; peer average 27.56/device2022-05: 0 reports for this device; peer average 72.31/device2022-06: 0 reports for this device; peer average 137.92/device2022-07: 0 reports for this device; peer average 121.47/device2022-08: 0 reports for this device; peer average 60.89/device2022-09: 0 reports for this device; peer average 49.58/device2022-10: 0 reports for this device; peer average 28.68/device2022-11: 0 reports for this device; peer average 31.04/device2022-12: 0 reports for this device; peer average 21.61/device2023-01: 0 reports for this device; peer average 27.29/device2023-02: 0 reports for this device; peer average 17.28/device2023-03: 0 reports for this device; peer average 11.6/device2023-04: 0 reports for this device; peer average 13.15/device2023-05: 0 reports for this device; peer average 17.38/device2023-06: 0 reports for this device; peer average 13.19/device2023-07: 0 reports for this device; peer average 15.42/device2023-08: 0 reports for this device; peer average 17.41/device2023-09: 0 reports for this device; peer average 15.25/device2023-10: 0 reports for this device; peer average 13.58/device2023-11: 0 reports for this device; peer average 20.66/device2023-12: 0 reports for this device; peer average 30.12/device2024-01: 0 reports for this device; peer average 28.88/device2024-02: 0 reports for this device; peer average 29.32/device2024-03: 0 reports for this device; peer average 31.32/device2024-04: 0 reports for this device; peer average 42.49/device2024-05: 0 reports for this device; peer average 48.47/device2024-06: 0 reports for this device; peer average 45.18/device2024-07: 0 reports for this device; peer average 40.08/device2024-08: 0 reports for this device; peer average 57.73/device2024-09: 0 reports for this device; peer average 46.55/device2024-10: 0 reports for this device; peer average 57.04/device2024-11: 0 reports for this device; peer average 44.67/device2024-12: 0 reports for this device; peer average 26.67/device2025-01: 0 reports for this device; peer average 33.93/device2025-02: 0 reports for this device; peer average 139.69/device2025-03: 0 reports for this device; peer average 141.31/device2025-04: 0 reports for this device; peer average 34.54/device2025-05: 0 reports for this device; peer average 12.99/device2025-06: 0 reports for this device; peer average 16.23/device2025-07: 0 reports for this device; peer average 12.56/device2025-08: 0 reports for this device; peer average 6.59/device2025-09: 0 reports for this device; peer average 7.87/device2025-10: 0 reports for this device; peer average 9.66/device2025-11: 0 reports for this device; peer average 89.89/device2025-12: 0 reports for this device; peer average 12.07/device2026-01: 0 reports for this device; peer average 21.81/device2026-02: 0 reports for this device; peer average 41.15/device2026-03: 0 reports for this device; peer average 40.31/device2026-04: 0 reports for this device; peer average 10.31/device2026-05: 0 reports for this device; peer average 80.56/device2026-06: 0 reports for this device; peer average 118.8/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0103.13
2019-0203.44
2019-0305.63
2019-0403.23
2019-0502.4
2019-0604.33
2019-0703.38
2019-0803.67
2019-0903
2019-1002.63
2019-1105.43
2019-1203.3
2020-0102.62
2020-0203
2020-0302
2020-0402.57
2020-0502
2020-0601.83
2020-0701.75
2020-0802.11
2020-0901.39
2020-1001.63
2020-1102.6
2020-1202.33
2021-0102.45
2021-0205.62
2021-03010.85
2021-0405.13
2021-0505.28
2021-0604.22
2021-0704.6
2021-0808.92
2021-0907.88
2021-10010.06
2021-11010.02
2021-12011.11
2022-01020.79
2022-02025.5
2022-03024.11
2022-04027.56
2022-05072.31
2022-060137.92
2022-070121.47
2022-08060.89
2022-09049.58
2022-10028.68
2022-11031.04
2022-12021.61
2023-01027.29
2023-02017.28
2023-03011.6
2023-04013.15
2023-05017.38
2023-06013.19
2023-07015.42
2023-08017.41
2023-09015.25
2023-10013.58
2023-11020.66
2023-12030.12
2024-01028.88
2024-02029.32
2024-03031.32
2024-04042.49
2024-05048.47
2024-06045.18
2024-07040.08
2024-08057.73
2024-09046.55
2024-10057.04
2024-11044.67
2024-12026.67
2025-01033.93
2025-020139.69
2025-030141.31
2025-04034.54
2025-05012.99
2025-06016.23
2025-07012.56
2025-0806.59
2025-0907.87
2025-1009.66
2025-11089.89
2025-12012.07
2026-01021.81
2026-02041.15
2026-03040.31
2026-04010.31
2026-05080.56
2026-060118.8
This device (reports/month)Average device in BTT, BZD (reports/device/month)

Regulatory clearances

  • K112079 SESE 2012-12-06 (k number procode)

Predicate lineage

K062664 — cited as predicate by K120035

K112079 — cites (transitively): K082979 (d1), K083656 (d1) — cited as predicate by K141522

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