FDA applicant

Civco Medical Solutions

Kalona, IA2 decisions2019–20230 recalls

FDA records 2 decisions for Civco Medical Solutions (Kalona, IA) from 2019 to 2023: 2 510(k) clearances. All are in product code ITX (Transducer, Ultrasonic, Diagnostic). Its devices cite 1 predicate, 0 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, radiology panel, where it files most

How often FDA has decided Civco Medical Solutions’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2019high 1 (2019) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — Civco Medical Solutions by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Civco Medical Solutions’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Civco”

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

CIVCO Medical Instruments Co., Inc. 31 Civco 2 Civco Medical Instruments CO Inc Dba Civco Medical… 1

Civco Medical Solutions

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?

Other applicant names beginning “Civco”