Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Enztec Limited — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
59 daysmedian FDA review time
132 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K232014 | CONDUITâ„¢ ATP Inserters | Enztec Limited | 2023-09-01 | 57 | 0 |
| K230876 | RI.KNEE Adjustable Tibia Cut Guide | Enztec Limited | 2023-06-27 | 89 | 0 |
| K223671 | CONDUIT LLIF Straight Inserters | Enztec Limited | 2023-01-05 | 29 | 0 |
| K220449 | DePuy CONDUIT LLIF SQUID Inserter | Enztec Limited | 2022-06-28 | 132 | 0 |
| K212823 | DePuy CONDUIT LLIF Angled Inserters | Enztec Limited | 2021-11-01 | 59 | 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