510(k) Report

FDA applicant

Eastern Cranial Affiliates, LLC

Fairfax, VA2 decisions2002–20180 recalls

FDA records 2 decisions for Eastern Cranial Affiliates, LLC (Fairfax, VA) from 2002 to 2018: 2 510(k) clearances. All are in product code MVA (Orthosis, Cranial). Its devices cite 2 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Eastern Cranial Affiliates”.

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 Eastern Cranial Affiliates, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2018: 1
2007high 1 (2018) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Eastern Cranial Affiliates, LLC by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Eastern Cranial Affiliates, LLC’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?

  • MVAOrthosis, Cranial2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 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.

  • K180568KidCapEastern Cranial Affiliates, LLC · 20181cites it
  • K020448Static Cranioplasty OrthosisEastern Cranial Affiliates · 20021cites it

What has FDA decided for it lately?

  • K180568KidCapEastern Cranial Affiliates, LLC · 2018
  • K020448Static Cranioplasty OrthosisEastern Cranial Affiliates · 2002

The one decision as Eastern Cranial Affiliates, LLC →The one decision as Eastern Cranial Affiliates →

Other applicant names beginning “Eastern”

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

Eastern Anesthesia, Inc. 2Eastern Laboratories, Ltd. 2Eastern Medikit, Ltd. 1Eastern Corp. 1Eastern Breeze Intl. Co. 1