510(k) Report

FDA applicant

Aperio Technologies

Vista, CA5 decisions2007–20090 recalls

FDA records 5 decisions for Aperio Technologies (Vista, CA) from 2007 to 2009: 5 510(k) clearances. Most are in product codes NOT (Microscope, Automated, Image Analysis…) and OEO (Automated Digital Image Manual Interpretation…). Its devices cite 6 predicates, 1 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 Aperio Technologies’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2007: 22008: 22009: 1
2007high 2 (2007) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Aperio”

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