FDA applicant
Robert I. Chien & Assoc., Inc.
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
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.
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.
See the 510(k) ReportOther applicant names beginning “Robert”
FDA records each applicant name separately; these may or may not be the same firm.