Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Z-Systems AG — Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
261 daysmedian FDA review time
425 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K201878 | ST-Z5 | Z-Systems AG | 2021-03-25 | 261 | 0 |
| K201712 | Z5-TL | Z-Systems AG | 2020-12-01 | 161 | 0 |
| K200386 | Z5-BL | Z-Systems AG | 2020-10-14 | 239 | 0 |
| K190243 | Z5-BL | Z-Systems AG | 2020-01-03 | 331 | 0 |
| K150021 | Z5m(t) | Z-Systems AG | 2015-07-31 | 206 | 0 |
| K132881 | Z5C | Z-Systems AG | 2014-07-03 | 293 | 0 |
| K131701 | Z5MLB, Z5MLC | Z-Systems AG | 2013-09-05 | 86 | 0 |
| K120793 | Z-LOOK3 EVO SLM | Z-Systems AG | 2012-12-21 | 281 | 0 |
| K062542 | Z-LOOK3 DENTAL IMPLANT SYSTEM, MODEL Z3-XXX | Z-Systems AG | 2007-10-29 | 425 | 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