Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Xenocor, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
26 daysmedian FDA review time
83 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260177 | Saberscope™ Laparoscope (SAS-A-536L); Xenocor® Video Process | Xenocor, Inc. | 2026-02-12 | 22 | 0 |
| K220872 | Saberscope5 Laparoscope | Xenocor, Inc. | 2022-04-20 | 26 | 0 |
| K193315 | Xenocor Articulating Xenoscope Laparoscope | Xenocor, Inc. | 2020-01-27 | 59 | 0 |
| K171344 | Xenocor Xenoscope Laparoscopic System | Xenocor, Inc. | 2017-06-01 | 24 | 0 |
| K161838 | Xenocor Xenoscope Laparoscopic System | Xenocor, Inc. | 2016-09-26 | 83 | 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