510(k) Report

FDA applicant

Winchester Laboratories, LLC

Batavia, IL1 decision1999–19990 recalls

FDA records 1 decision for Winchester Laboratories, LLC (Batavia, IL) in 1999: 1 510(k) clearance. All are in product code FRO (Dressing, Wound, Drug). 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 Winchester Laboratories, LLC’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Winchester Laboratories, LLC since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Winchester Laboratories, LLC by year, 2007–2026Sources: 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, Drug1decision

Who builds on its devices?

Later devices cite its devices 2 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.

  • K993969Saljet Single Dose Sterile Saline Topical SolutionWinchester Laboratories, LLC · 19992cite it

What has FDA decided for it lately?

  • K993969Saljet Single Dose Sterile Saline Topical SolutionWinchester Laboratories, LLC · 1999

The one decision as Winchester Laboratories, LLC →

Other applicant names beginning “Winchester”

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

Winchester Industries, Inc. 1