FDA applicant
Aloka Co., Ltd.
FDA records 39 decisions for Aloka Co., Ltd. (Wallingford, CT) from 1982 to 2011: 39 510(k) clearances. Most are in product codes IYN (System, Imaging, Pulsed Doppler, Ultrasonic) and ITX (Transducer, Ultrasonic, Diagnostic). Its devices cite 25 predicates, 21 of them its own earlier devices. 4 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Aloka Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2011
2026 so far, outlined.
Recalls per year
1in 2023
Class I Class II/III not classified
Planning a device like Aloka Co., 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) ReportOther applicant names beginning “Aloka”
FDA records each applicant name separately; these may or may not be the same firm.