FDA applicant
CIVCO Medical Instruments Co., Inc.
FDA records 31 decisions for CIVCO Medical Instruments Co., Inc. (Kalona, IA) from 1982 to 2026: 31 510(k) clearances. Most are in product codes ITX (Transducer, Ultrasonic, Diagnostic) and IYO (System, Imaging, Pulsed Echo, Ultrasonic). Since 2016 its 510(k)s took a median of 151 days from receipt to decision, against 151 for FDA’s reviews in the same codes and years. Its devices cite 32 predicates, 12 of them its own earlier devices. 13 recalls are linked to its devices.
FDA’s records also spell it “Civco Medical Instruments”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided CIVCO Medical Instruments Co., Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2023
2026 so far, outlined.
Recalls per year
1in 2025
Class I Class II/III not classified
Planning a device like CIVCO Medical Instruments Co., Inc.’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 “CIVCO”
FDA records each applicant name separately; these may or may not be the same firm.