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CARDINAL HEALTH

Model CF-1001 · Cardinal Health 200, LLC · DI 10885380009020

OCT — Anti Fog Solution And Accessories, Endoscopy · Class II · 21 CFR 876.1500

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.

12232019-02: 0 reports for this device; peer average 2/device2019-12: 0 reports for this device; peer average 2/device2021-08: 0 reports for this device; peer average 1/device2021-11: 0 reports for this device; peer average 2/device2023-08: 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 1/device2024-07: 0 reports for this device; peer average 1/device2024-08: 0 reports for this device; peer average 1/device2024-09: 0 reports for this device; peer average 1/device2024-10: 0 reports for this device; peer average 1.5/device2024-11: 0 reports for this device; peer average 1/device2025-01: 0 reports for this device; peer average 1/device2025-02: 0 reports for this device; peer average 1/device2025-03: 0 reports for this device; peer average 1.5/device2025-05: 0 reports for this device; peer average 1.5/device2025-07: 0 reports for this device; peer average 1.5/device2025-08: 0 reports for this device; peer average 1.33/device2025-09: 0 reports for this device; peer average 1/device2025-10: 0 reports for this device; peer average 1.6/device2025-12: 0 reports for this device; peer average 1.67/device2026-03: 0 reports for this device; peer average 3/device2026-05: 0 reports for this device; peer average 3/device021208110811030507080910110102030507080910120305
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0202
2019-1202
2021-0801
2021-1102
2023-0801
2023-1101
2024-0301
2024-0501
2024-0701
2024-0801
2024-0901
2024-1001.5
2024-1101
2025-0101
2025-0201
2025-0301.5
2025-0501.5
2025-0701.5
2025-0801.33
2025-0901
2025-1001.6
2025-1201.67
2026-0303
2026-0503
This device (reports/month)Average device in OCT (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K932449 — cited as predicate by K190864, K231822

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

Manufacturer compliance record — Cardinal Health 200, LLC

  • Warning Letter 2024-04-24 Cardinal Health 200, LLC
  • Warning Letter 2024-04-24 Cardinal Health 200, LLC
  • OAI 2023-12-20 Cardinal Health 200, LLC · 3 citations
  • OAI 2023-12-20 Cardinal Health 200, LLC · 3 citations
  • VAI 2023-10-26 Aero-Med LLC · 2 citations
  • NAI 2023-05-05 Cardinal Health 200, LLC · 0 citations
  • NAI 2023-05-05 Cardinal Health 200, LLC · 0 citations
  • NAI 2023-01-12 Ludlow Technical Products Canada, Ltd. (A Division of Cardinal Health LLC) · 0 citations
  • NAI 2020-02-19 Cardinal Health Inc. · 0 citations
  • VAI 2018-12-21 Aero-Med LLC · 2 citations
  • VAI 2017-11-15 Cardinal Health LLC · 1 citations
  • NAI 2017-07-13 Cardinal Health D.R. 203 II LTD · 0 citations
  • VAI 2017-01-25 Cardinal Health · 4 citations
  • NAI 2016-11-16 Cardinal Health Ireland Manufacturing Limited · 0 citations
  • VAI 2016-11-16 Cardinal Health PR 218 Inc · 0 citations
  • NAI 2016-08-25 Cardinal Health 200, LLC · 0 citations
  • NAI 2016-08-25 Cardinal Health 200, LLC · 0 citations
  • NAI 2016-08-23 Cardinal Health 200, LLC · 0 citations
  • VAI 2016-05-12 Cardinal Health · 0 citations
  • NAI 2016-03-23 Cardinal Health LLC · 0 citations
  • VAI 2016-01-28 Ludlow Technical Products Canada, Ltd. (A Division of Cardinal Health LLC) · 2 citations
  • NAI 2015-11-18 Cardinal Health · 0 citations