510(k) Report

FDA applicant

Digit-Pro

Houston, TX1 decision2000–20000 recalls

FDA records 1 decision for Digit-Pro (Houston, TX) in 2000: 1 510(k) clearance. All are in product code LZB (Finger Cot). 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, general hospital panel, where it files most

How often FDA has decided Digit-Pro’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Digit-Pro since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Digit-Pro 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?

  • LZBFinger Cot1decision

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.

  • K992539PercuguardDigit-Pro · 20002cite it

What has FDA decided for it lately?

The one decision as Digit-Pro →