510(k) Report

FDA applicant

Latex Ind., Inc.

Mchenry, IL14 decisions1977–19810 recalls

FDA records 14 decisions for Latex Ind., Inc. (Mchenry, IL) from 1977 to 1981: 14 510(k) clearances. Most are in product codes FCM (Tray, Catheterization, Sterile Urethral, With…) and KOD (Catheter, Urological). 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 Latex Ind., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Latex Ind., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Latex Ind., 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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Other applicant names beginning “Latex”

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