510(k) Report

FDA applicant

Midlothian Laboratories

Montgomery, AL2 decisions2009–20100 recalls

FDA records 2 decisions for Midlothian Laboratories (Montgomery, AL) from 2009 to 2010: 2 510(k) clearances. All are in product code FRO (Dressing, Wound, Drug). Its devices cite 7 predicates, 1 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

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

FDA decisions per year

1in 2010

2009: 12010: 1
2009high 1 (2009) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Midlothian Laboratories by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FRODressing, Wound, Drug2decisions

Whose devices does it build on?

Its devices cite 7 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 1 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.

  • K090337Tropazone LotionMidlothian Laboratories · 20092cite it
  • K093544Tropazone CRMidlothian Laboratories · 20101cites it

What has FDA decided for it lately?

  • K093544Tropazone CRMidlothian Laboratories · 2010
  • K090337Tropazone LotionMidlothian Laboratories · 2009

All 2 as Midlothian Laboratories →