FDA applicant

Sienco, Inc.

Boulder, CO5 decisions1995–20230 recalls

FDA records 5 decisions for Sienco, Inc. (Boulder, CO) from 1995 to 2023: 5 510(k) clearances. Most are in product codes JBP (Activated Whole Blood Clotting Time) and JPA (System, Multipurpose For In Vitro Coagulation…). Its devices cite 4 predicates, 4 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, hematology panel, where it files most

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

FDA decisions per year

1in 2023

2007high 1 (2023) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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Sienco, Inc.

Which product codes does it file in?

Which of its devices are cited most?

What has FDA decided for it lately?