510(k) Report

FDA applicant

Pentax Corp.

Chevy Chase, MD1 decision2007–20070 recalls

FDA records 1 decision for Pentax Corp. (Chevy Chase, MD) in 2007: 1 510(k) clearance. All are in product code MQV (Filler, Bone Void, Calcium Compound). 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, orthopedic panel, where it files most

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

FDA decisions per year

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Pentax Corp. 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?

  • MQVFiller, Bone Void, Calcium Compound1decision

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.

  • K071912Apaceram Bone Graft SubstitutePentax Corp. · 20071cites it

What has FDA decided for it lately?

  • K071912Apaceram Bone Graft SubstitutePentax Corp. · 2007

The one decision as Pentax Corp. →

Other applicant names beginning “Pentax”

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

Pentax Precision Instrument Corp. 67Pentax of America, Inc. 44Pentax Medical Company 18Pentax Medical of America, Inc. 2Pentax Medical, A Division of Pentax of America, Inc. 2