Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
OTD · Predicate Candidate Screening
7 FDA 510(k) clearances under this product code; the 50 most recent screened below.
30 daysmedian FDA review time
342 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K182957 | Heli-FX EndoAnchor System | Medtronic Vascular, Inc. | 2018-11-21 | 28 | 0 |
| K171427 | Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor Cassett | Medtronic Vascular, Inc. | 2017-06-13 | 29 | 0 |
| K141041 | APTUS HELI-FX ANCILLARY ENDOANCHOR CASSETTE | Aptus Endosystems | 2014-05-16 | 23 | 0 |
| K140036 | APTUS HELI-FX GUIDE - 22CM DEFLECTABLE LENGTH; APTUS HELI-FX | Aptus Endosystems, Inc. | 2014-02-06 | 30 | 0 |
| K130677 | APTUS HELI-FX AORTIC SECUREMENT SYSTEM | Aptus Endosystems, Inc. | 2013-04-12 | 30 | 0 |
| K121168 | APTUS 18FR HELIFX GUIDE-22 DEFLECTABLE LENGTH | Aptus Endosystems, Inc. | 2012-08-08 | 113 | 0 |
| DEN100026 | APTUS STEERABLE ENDOGUIDE WITH OBTURATOR, APTUS ENDOSTAPLE A | Aptus Endosystems, Inc. | 2011-11-21 | 342 | 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