510(k) Report

FDA applicant

Lone Star Medical Products, Inc.

Mchenry, IL6 decisions1979–19851 recall

FDA records 6 decisions for Lone Star Medical Products, Inc. (Mchenry, IL) from 1979 to 1985: 6 510(k) clearances. Most are in product codes KOA (Surgical Instruments, G-U, Manual (And…) and GAD (Retractor). 1 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 Lone Star Medical Products, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Lone Star Medical Products, Inc. since 2007.

Recalls per year

1in 2018

2018: 1
2007high 1 (2018) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Lone Star Medical Products, Inc.’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 “Lone”

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