510(k) Report

FDA applicant

Bpendo, LLC

Norman, OK2 decisions2022–20260 recalls

FDA records 2 decisions for Bpendo, LLC (Norman, OK) from 2022 to 2026: 2 510(k) clearances. All are in product code FDF (Colonoscope And Accessories, Flexible/Rigid). Its devices cite 2 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “BPEndo, LLC”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Bpendo, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2022: 12026 (partial year): 1
2022high 1 (2022) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

FIG. 1 — Bpendo, LLC by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FDFColonoscope And Accessories, Flexible/Rigid2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K213773Insufflation Retention DeviceBpendo, LLC · 20221cites it

What has FDA decided for it lately?

  • K261587Insufflation Retention Device (IRD) (11173-325-101)BPEndo, LLC · 2026
  • K213773Insufflation Retention DeviceBpendo, LLC · 2022

The one decision as Bpendo, LLC →The one decision as BPEndo, LLC →