510(k) Report

FDA applicant

Barzell-Whitmore Maroon Bells, Inc.

Appollo Beach, FL2 decisions1997–20000 recalls

FDA records 2 decisions for Barzell-Whitmore Maroon Bells, Inc. (Appollo Beach, FL) from 1997 to 2000: 2 510(k) clearances. Most are in product codes IYO (System, Imaging, Pulsed Echo, Ultrasonic) and ITX (Transducer, Ultrasonic, Diagnostic). Its devices cite 4 predicates, 0 of them its own earlier devices. No 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, radiology panel, where it files most

How often FDA has decided Barzell-Whitmore Maroon Bells, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Barzell-Whitmore Maroon Bells, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Barzell-Whitmore Maroon Bells, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Barzell-Whitmore Maroon Bells, 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?

  • IYOSystem, Imaging, Pulsed Echo, Ultrasonic1decision
  • ITXTransducer, Ultrasonic, Diagnostic1decision

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 0 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.

  • K972672Brachystepper Stepping Unit, Brachystepper Needle Guide Template, Brachystand Support and Manual Adjustment…Barzell-Whitmore Maroon Bells, Inc. · 19974cite it
  • K000960Barzell-Whitmore Maroon Bells, Inc. Colo-Rectal Mover, Model 3900Barzell-Whitmore Maroon Bells, Inc. · 20002cite it

What has FDA decided for it lately?

  • K000960Barzell-Whitmore Maroon Bells, Inc. Colo-Rectal Mover, Model 3900Barzell-Whitmore Maroon Bells, Inc. · 2000
  • K972672Brachystepper Stepping Unit, Brachystepper Needle Guide Template, Brachystand Support and Manual Adjustment…Barzell-Whitmore Maroon Bells, Inc. · 1997

All 2 as Barzell-Whitmore Maroon Bells, Inc. →