Skip to content
Print-ready dossier — use your browser's print dialog to save as PDF.

Bioteque America, Inc.

Model CU8 · Bioteque America, Inc. · DI 00810142350280

HHW — Pessary, Vaginal · Class II · 21 CFR 884.3575

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.

153045602019-03: 0 reports for this device; peer average 2/device2019-08: 0 reports for this device; peer average 1/device2019-09: 0 reports for this device; peer average 1/device2019-11: 0 reports for this device; peer average 1.33/device2020-01: 0 reports for this device; peer average 60.14/device2020-02: 0 reports for this device; peer average 1.75/device2020-03: 0 reports for this device; peer average 2.67/device2020-04: 0 reports for this device; peer average 1.5/device2020-05: 0 reports for this device; peer average 1.5/device2020-06: 0 reports for this device; peer average 1/device2020-07: 0 reports for this device; peer average 2.5/device2020-08: 0 reports for this device; peer average 1/device2020-09: 0 reports for this device; peer average 2.08/device2020-10: 0 reports for this device; peer average 1.33/device2020-11: 0 reports for this device; peer average 1.22/device2020-12: 0 reports for this device; peer average 1.25/device2021-01: 0 reports for this device; peer average 2/device2021-02: 0 reports for this device; peer average 1.13/device2021-03: 0 reports for this device; peer average 1/device2021-06: 0 reports for this device; peer average 1/device2021-08: 0 reports for this device; peer average 1/device2021-09: 0 reports for this device; peer average 1/device2021-10: 0 reports for this device; peer average 1.08/device2021-11: 0 reports for this device; peer average 1.17/device2022-03: 0 reports for this device; peer average 1/device2022-04: 0 reports for this device; peer average 3/device2022-05: 0 reports for this device; peer average 1/device2022-06: 0 reports for this device; peer average 1/device2022-11: 0 reports for this device; peer average 1.5/device2023-01: 0 reports for this device; peer average 1.17/device2023-03: 0 reports for this device; peer average 1/device2023-05: 0 reports for this device; peer average 2/device2023-06: 0 reports for this device; peer average 1/device2023-08: 0 reports for this device; peer average 1.5/device2023-09: 0 reports for this device; peer average 1/device2023-11: 0 reports for this device; peer average 1.43/device2024-08: 0 reports for this device; peer average 2/device2024-12: 0 reports for this device; peer average 1/device2025-01: 0 reports for this device; peer average 2/device2025-03: 0 reports for this device; peer average 3/device2025-05: 0 reports for this device; peer average 1.33/device2025-08: 0 reports for this device; peer average 1/device2025-10: 0 reports for this device; peer average 5/device2025-11: 0 reports for this device; peer average 1/device2025-12: 0 reports for this device; peer average 1/device2026-05: 0 reports for this device; peer average 2/device03080911010203040506070809101112010203060809101103040506110103050608091108120103050810111205
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0302
2019-0801
2019-0901
2019-1101.33
2020-01060.14
2020-0201.75
2020-0302.67
2020-0401.5
2020-0501.5
2020-0601
2020-0702.5
2020-0801
2020-0902.08
2020-1001.33
2020-1101.22
2020-1201.25
2021-0102
2021-0201.13
2021-0301
2021-0601
2021-0801
2021-0901
2021-1001.08
2021-1101.17
2022-0301
2022-0403
2022-0501
2022-0601
2022-1101.5
2023-0101.17
2023-0301
2023-0502
2023-0601
2023-0801.5
2023-0901
2023-1101.43
2024-0802
2024-1201
2025-0102
2025-0303
2025-0501.33
2025-0801
2025-1005
2025-1101
2025-1201
2026-0502
This device (reports/month)Average device in HHW (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K013289 — cited as predicate by K231786

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

Manufacturer compliance record — Bioteque America, Inc.

  • VAI 2025-04-23 Bioteque America, Inc · 6 citations
  • VAI 2025-04-23 Bioteque America, Inc · 6 citations
  • VAI 2013-07-15 Bioteque America, Inc. · 1 citations
  • VAI 2011-06-24 Bioteque America, Inc. · 6 citations