510(k) Report

FDA applicant

Principle Business Ent.

Mchenry, IL3 decisions1981–19840 recalls

FDA records 3 decisions for Principle Business Ent. (Mchenry, IL) from 1981 to 1984: 3 510(k) clearances. Most are in product codes EYQ (Garment, Protective, For Incontinence) and FRG (Wrap, Sterilization). 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 Principle Business Ent.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Principle Business Ent. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Principle”

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