Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Bend IT Technologies, Ltd. — 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) |
|---|---|---|---|---|---|
| K252213 | Bendit17 Microcatheter | Bend IT Technologies, Ltd. | 2025-12-03 | 141 | 0 |
| K203842 | Bendit21 Microcatheter | Bend IT Technologies, Ltd. | 2022-04-13 | 468 | 0 |
| K200582 | Bendit2.7 Steerable Microcatheter | Bend IT Technologies, Ltd. | 2020-06-25 | 111 | 0 |
| K190126 | Bendit2.7 Steerable Microcatheter | Bend IT Technologies, Ltd. | 2019-08-22 | 206 | 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