510(k) Report

FDA applicant

Aggredyne, Inc.

Houston, TX3 decisions2013–20191 recall

FDA records 3 decisions for Aggredyne, Inc. (Houston, TX) from 2013 to 2019: 3 510(k) clearances. All are in product code JOZ (System, Automated Platelet Aggregation). Its devices cite 3 predicates, 1 of them its own earlier devices. 1 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 Aggredyne, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2013: 12017: 12019: 1
2013high 1 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

1in 2019

2019: 1
2013high 1 (2019) · low 0 (2013)2026

Class I Class II/III not classified

FIG. 1 — Aggredyne, Inc. by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • JOZSystem, Automated Platelet Aggregation3decisions

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K122162AggreguideAggredyne, Inc. · 20131cites it

What has FDA decided for it lately?

  • K181777AggreGuide A-100 ADPAggredyne, Inc. · 20191 recall
  • K163274AggreGuide A-100 AA Assay, AggreGuide A-100 InstrumentAggredyne, Inc. · 20171 recall
  • K122162AggreguideAggredyne, Inc. · 20131 recall

All 3 as Aggredyne, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K122162AggreGuide A-100 InstrumentJul 23, 2019Class II