510(k) Report

FDA applicant

Bryan Medical, Inc.

Cincinnati, OH4 decisions2015–20261 recall

FDA records 4 decisions for Bryan Medical, Inc. (Cincinnati, OH) from 2015 to 2026: 4 510(k) clearances. Most are in product codes BTR (Tube, Tracheal (W/Wo Connector)) and KTI (Bronchoscope Accessory). Its devices cite 5 predicates, 2 of them its own earlier devices. 1 recall is linked to its devices.

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

FIG. A — Illustration, anesthesiology panel, where it files most

How often FDA has decided Bryan Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2015: 12020: 12021: 12026 (partial year): 1
2015high 1 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

1in 2023

2023: 1
2015high 1 (2023) · low 0 (2015)2026

Class I Class II/III not classified

FIG. 1 — Bryan Medical, Inc. by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Bryan Medical, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • BTRTube, Tracheal (W/Wo Connector)3decisions
  • KTIBronchoscope Accessory1decision

Whose devices does it build on?

Its devices cite 5 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 2 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K200761Tenax Laser Resistant Endotracheal TubeBryan Medical, Inc. · 20201cites it
  • K213028Tenax Laser Resistant Endotracheal TubeBryan Medical, Inc. · 20211cites it
  • K150951aeris Balloon Dialation CatheterBryan Medical, Inc. · 20151cites it

What has FDA decided for it lately?

  • K251794Tenax® Laser Resistant Endotracheal TubeBryan Medical, Inc. · 2026
  • K213028Tenax Laser Resistant Endotracheal TubeBryan Medical, Inc. · 2021
  • K200761Tenax Laser Resistant Endotracheal TubeBryan Medical, Inc. · 2020
  • K150951aeris Balloon Dialation CatheterBryan Medical, Inc. · 20151 recall

All 4 as Bryan Medical, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K150951Aeris Balloon Dilation CatheterMay 16, 2023Class II

Other applicant names beginning “Bryan”

FDA records each applicant name separately; these may or may not be the same firm.

Bryan Corp. 5Bryan Keropian Dds 4