510(k) Report

FDA applicant

Pentapharm, Ltd.

Washington, DC3 decisions2004–20102 recalls

FDA records 3 decisions for Pentapharm, Ltd. (Washington, DC) from 2004 to 2010: 3 510(k) clearances. Most are in product codes GGN (Plasma, Coagulation Control) and GGW (Test, Time, Partial Thromboplastin). Its devices cite 3 predicates, 0 of them its own earlier devices. 2 recalls are linked to its devices.

FDA’s records also spell it “Pentapharm GmbH”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, hematology panel, where it files most

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

FDA decisions per year

1in 2010

2010: 1
2007high 1 (2010) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2016

2014: 12016: 1
2007high 1 (2014) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Pentapharm, Ltd. 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?

  • GGNPlasma, Coagulation Control1decision
  • GGWTest, Time, Partial Thromboplastin1decision
  • JPASystem, Multipurpose For In Vitro Coagulation Studies1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

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.

  • K083842Rotem Delta Thromboelastometry SystemPentapharm GmbH · 20102cite it

What has FDA decided for it lately?

  • K083842Rotem Delta Thromboelastometry SystemPentapharm GmbH · 20102 recalls
  • K042760Pefakit Apc-R Factor V Leiden ControlsPentapharm, Ltd. · 2004
  • K042762Pefakit Apc-R Factor V LeidenPentapharm, Ltd. · 2004

All 2 as Pentapharm, Ltd. →The one decision as Pentapharm GmbH →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K083842ROTROL P Control for ROTEM delta Thromboelastometry System, For In Vitro Diagnostic Use…Feb 18, 2016Class II
  • K083842ROTROL P Control for ROTEM delta Thromboelastometry System, Manufactured for: Tem…Oct 23, 2014Class II