Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Endologix, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
57 daysmedian FDA review time
171 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K120212 | AFX INTRODUCER SYSTEM | Endologix, Inc. | 2012-02-09 | 16 | 1 |
| K111747 | ENDOLOGIX AFX INTRODUCER SYSTEM | Endologix, Inc. | 2011-07-12 | 20 | 0 |
| K110090 | AFX INTRODUCER SYSTEM | Endologix, Inc. | 2011-05-26 | 134 | 0 |
| K080360 | ENDOLOGIX VISIFLEX DUAL LUMEN CATHETER | Endologix, Inc. | 2008-04-08 | 57 | 0 |
| K991601 | DUAL LUMEN CATHETER, MODEL DL-35-90 | Endologix, Inc. | 1999-10-28 | 171 | 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