510(k) Report

FDA applicant

Flotec, Inc.

Indianapolis, IN2 decisions1990–19970 recalls

FDA records 2 decisions for Flotec, Inc. (Indianapolis, IN) from 1990 to 1997: 2 510(k) clearances. Most are in product codes CAN (Regulator, Pressure, Gas Cylinder) and NFB (Conserver, Oxygen). 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, anesthesiology panel, where it files most

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

FDA decisions per year

No FDA decision for Flotec, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Flotec, 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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