Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
International Life Sciences — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260317 | Artelon Convenience Kits | International Life Sciences | 2026-04-09 | 69 | 0 |
| K230316 | FlexBand; FlexPatch; FlexBand Plus | International Life Sciences | 2023-05-26 | 109 | 3 |
| K200503 | ATL Anchors | International Life Sciences | 2020-09-02 | 184 | 2 |
| K192112 | FlexBand Plus | International Life Sciences | 2019-09-27 | 53 | 0 |
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