FDA applicant
King Systems Corp.
FDA records 18 decisions for King Systems Corp. (Noblesville, IN) from 1988 to 2004: 18 510(k) clearances. Most are in product codes CAH (Filter, Bacterial, Breathing-Circuit) and CAE (Airway, Oropharyngeal, Anesthesiology). Its devices cite 2 predicates, 2 of them its own earlier devices. 31 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided King Systems Corp.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for King Systems Corp. since 2007.
Recalls per year
1in 2017
Class I Class II/III not classified
Planning a device like King Systems 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) ReportOther applicant names beginning “King”
FDA records each applicant name separately; these may or may not be the same firm.