FDA applicant

Fluoro-Mold Co.

Mchenry, IL1 decision1977–19770 recalls

FDA records 1 decision for Fluoro-Mold Co. (Mchenry, IL) in 1977: 1 510(k) clearance. All are in product code FJS (Catheter, Peritoneal, Long-Term Indwelling). 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, gastroenterology and urology panel, where it files most

How often FDA has decided Fluoro-Mold Co.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Fluoro-Mold Co. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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

See the 510(k) Report

Other applicant names beginning “Fluoro-Mold”

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

Fluoro Scan Imaging Systems, Inc. 1

Fluoro-Mold Co.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Fluoro-Mold”