FDA applicant
Terragene S.A.
FDA records 9 decisions for Terragene S.A. (Alvear, AR) from 2017 to 2025: 8 510(k) clearances and 1 De Novo grant. Most are in product codes FRC (Indicator, Biological Sterilization Process) and JOJ (Indicator, Physical/Chemical Sterilization…). Since 2016 its 510(k)s took a median of 149 days from receipt to decision, against 105 for FDA’s reviews in the same codes and years. Its devices cite 2 predicates, 2 of them its own earlier devices. 3 recalls are linked to its devices.
FDA’s records also spell it “Terragene”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Terragene S.A.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
1in 2025
Class I Class II/III not classified
Planning a device like Terragene S.A.’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