510(k) Report

FDA applicant

Robert I. Chien & Assoc., Inc.

Mchenry, IL6 decisions1980–19820 recalls

FDA records 6 decisions for Robert I. Chien & Assoc., Inc. (Mchenry, IL) from 1980 to 1982: 6 510(k) clearances. Most are in product codes HXD (Clamp) and GDY (Gauze/Sponge, Internal, X-Ray Detectable). 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, general and plastic surgery panel, where it files most

How often FDA has decided Robert I. Chien & Assoc., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Robert I. Chien & Assoc., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Robert I. Chien & Assoc., 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 “Robert”

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