510(k) Report

FDA applicant

Scott E Allen CP

Salt Lake City, UT1 decision2002–20020 recalls

FDA records 1 decision for Scott E Allen CP (Salt Lake City, UT) in 2002: 1 510(k) clearance. All are in product code MVA (Orthosis, Cranial). Its devices cite 2 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, neurology panel, where it files most

How often FDA has decided Scott E Allen CP’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Scott E Allen CP since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Scott E Allen CP 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?

  • MVAOrthosis, Cranial1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K012804Plagiocephalic Applied Pressure Orthosis P.a.P. OrthosisScott E Allen CP · 20021cites it

What has FDA decided for it lately?

  • K012804Plagiocephalic Applied Pressure Orthosis P.a.P. OrthosisScott E Allen CP · 2002

The one decision as Scott E Allen CP →

Other applicant names beginning “Scott”

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

Scott Laboratories, Inc. 17Scott Health Care 9Scott Imaging Intl., Inc. 7Scott Paper Co. 3Scott All-Sports, Inc. 2The Scott & Fetzer Co. 1Scott Feldman Dds & Norman Shapiro Dds 1Scott/Ross Designs, Inc. 1