FDA applicant
Prentke Romich Co.
FDA records 9 decisions for Prentke Romich Co. (Wooster, OH) from 1990 to 1996: 9 510(k) clearances. Most are in product codes ILQ (System, Communication, Powered) and IQA (System, Environmental Control, Powered). 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 Prentke Romich Co.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Prentke Romich Co. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Prentke Romich Co.’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