FDA applicant
Rae Medical Corp.
FDA records 3 decisions for Rae Medical Corp. (Mchenry, IL) from 1978 to 1983: 3 510(k) clearances. Most are in product codes DSF (Recorder, Paper Chart) and DXJ (Display, Cathode-Ray Tube, Medical). 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 Rae Medical Corp.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Rae Medical Corp. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Rae Medical Corp.’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