FDA applicant
Caradyne, Ltd.
FDA records 5 decisions for Caradyne, Ltd. (Mccordsville, IN) from 1999 to 2004: 5 510(k) clearances. Most are in product codes CAP (Monitor, Airway Pressure (Includes Gauge…) and CCL (Analyzer, Gas, Oxygen, Gaseous-Phase). Its devices cite 12 predicates, 1 of them its own earlier devices. 2 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Caradyne, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Caradyne, Ltd. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Caradyne, Ltd.’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