Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Voluntis Sa. · Predicate Candidate Screening

5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

120 daysmedian FDA review time
269 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K232451Insulia Bolus CompanionVoluntis Sa.2023-12-121200
K202596Insulia Diabetes Management CompanionVoluntis Sa.2021-06-042690
K172177Insulia Diabetes Management CompanionVoluntis Sa.2017-11-071110
K170669Insulia Diabetes Management CompanionVoluntis Sa.2017-06-191050
K161433Insulia Diabetes Management CompanionVoluntis Sa.2016-11-091690

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda