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AincA®

Model 00-392-S · ANESTHESIA ASSOCIATES, INC. · DI B00500392S0

JAY — Support, Breathing Tube · Class I · 21 CFR 868.5280

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.

51015202019-02: 0 reports for this device; peer average 20/device2019-03: 0 reports for this device; peer average 1/device2019-04: 0 reports for this device; peer average 1/device2019-05: 0 reports for this device; peer average 1/device2019-08: 0 reports for this device; peer average 1/device2019-09: 0 reports for this device; peer average 1/device2019-10: 0 reports for this device; peer average 1/device2020-02: 0 reports for this device; peer average 19/device2020-08: 0 reports for this device; peer average 1/device2020-09: 0 reports for this device; peer average 1/device2020-12: 0 reports for this device; peer average 2/device2021-01: 0 reports for this device; peer average 1/device2021-04: 0 reports for this device; peer average 7/device2021-07: 0 reports for this device; peer average 1/device2021-12: 0 reports for this device; peer average 1/device2022-03: 0 reports for this device; peer average 1/device2022-04: 0 reports for this device; peer average 1/device2022-07: 0 reports for this device; peer average 1/device2022-08: 0 reports for this device; peer average 1/device2022-11: 0 reports for this device; peer average 1/device2022-12: 0 reports for this device; peer average 2/device2023-01: 0 reports for this device; peer average 1/device2023-02: 0 reports for this device; peer average 3.5/device2023-03: 0 reports for this device; peer average 1/device2023-06: 0 reports for this device; peer average 1/device2023-08: 0 reports for this device; peer average 1/device2023-09: 0 reports for this device; peer average 1/device2023-11: 0 reports for this device; peer average 1/device2024-03: 0 reports for this device; peer average 1/device2024-05: 0 reports for this device; peer average 4/device2024-07: 0 reports for this device; peer average 1/device2024-10: 0 reports for this device; peer average 3/device2025-04: 0 reports for this device; peer average 1/device2025-11: 0 reports for this device; peer average 3/device2026-01: 0 reports for this device; peer average 3/device2026-03: 0 reports for this device; peer average 9/device2026-04: 0 reports for this device; peer average 3/device02030405080910020809120104071203040708111201020306080911030507100411010304
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-02020
2019-0301
2019-0401
2019-0501
2019-0801
2019-0901
2019-1001
2020-02019
2020-0801
2020-0901
2020-1202
2021-0101
2021-0407
2021-0701
2021-1201
2022-0301
2022-0401
2022-0701
2022-0801
2022-1101
2022-1202
2023-0101
2023-0203.5
2023-0301
2023-0601
2023-0801
2023-0901
2023-1101
2024-0301
2024-0504
2024-0701
2024-1003
2025-0401
2025-1103
2026-0103
2026-0309
2026-0403
This device (reports/month)Average device in JAY (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — ANESTHESIA ASSOCIATES, INC.

  • VAI 2023-12-18 Anesthesia Associates Inc · 7 citations
  • VAI 2023-12-18 Anesthesia Associates Inc · 7 citations
  • VAI 2019-03-14 Anesthesia Associates Inc · 3 citations
  • VAI 2019-03-14 Anesthesia Associates Inc · 3 citations