Atlas FDA

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

S.M.A.I.O — Predicate Candidate Screening

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

96 daysmedian FDA review time
215 days90th percentile
11clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K253802KHEIRON® Spinal Fixation System, including patient specific S.M.A.I.O2026-07-012150
K260786KHEIRON® Spinal Fixation System, including patient specific S.M.A.I.O2026-04-03240
K253990KHEIRON® Spinal Fixation System, including patient specific S.M.A.I.O2026-01-07260
K253721KHEIRON® Spinal Fixation System, including patient specific S.M.A.I.O2025-12-17230
K251804KHEIRON® Spinal Fixation System, including patient specific S.M.A.I.O2025-07-08260
K232650KHEIRON® Spinal Fixation System, including patient specific S.M.A.I.O2023-09-29290
K223841KBA3DS.M.A.I.O2023-05-301590
K211981KHEIRON® Spinal Fixation SystemS.M.A.I.O2022-06-093490
K213975KEOPS Balance Analyzer 3DS.M.A.I.O2022-05-061370
K211414KHEIRON Spinal Fixation SystemS.M.A.I.O2021-08-10960
K201659KHEIRON® Spinal Fixation SystemS.M.A.I.O2020-10-051090

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