510(k) Report

FDA applicant

Flowtronics, Inc.

Phoenix, AZ1 decision1985–19850 recalls

FDA records 1 decision for Flowtronics, Inc. (Phoenix, AZ) in 1985: 1 510(k) clearance. All are in product code LME (Monitor, Blood-Flow, Cerebral, Thermal Diffusion). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

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

FDA decisions per year

No FDA decision for Flowtronics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Flowtronics, 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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