FDA applicant

Clearflow, Inc.

Anaheim, CA6 decisions2015–20210 recalls

FDA records 6 decisions for Clearflow, Inc. (Anaheim, CA) from 2015 to 2021: 6 510(k) clearances. All are in product code OTK (Wound Drain Catheter System). Its devices cite 5 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, general and plastic surgery panel, where it files most

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

FDA decisions per year

1in 2021

2015high 2 (2016) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Clearflow, Inc. by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Clearflow, Inc.’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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Clearflow, Inc.

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?