FDA applicant

Accumetrics, Inc.

San Diego, CA7 decisions1999–20159 recalls

FDA records 7 decisions for Accumetrics, Inc. (San Diego, CA) from 1999 to 2015: 7 510(k) clearances. All are in product code JOZ (System, Automated Platelet Aggregation). Its devices cite 8 predicates, 1 of them its own earlier devices. 9 recalls are 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 Accumetrics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2007high 1 (2015) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2025

2007high 2 (2012) · low 0 (2007)2026

Class I Class II/III not classified

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

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Accumetrics, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?