Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Endophys Holdings, LLC — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K190098 | Endophys Pressure Sensing Sheath | Endophys Holdings, LLC | 2019-03-07 | 44 | 0 |
| K180620 | Endophys Pressure Sensing Sheath Kit | Endophys Holdings, LLC | 2018-10-12 | 217 | 0 |
| K173399 | Endophys Pressure Sensing Sheath Kit- 8F | Endophys Holdings, LLC | 2017-11-30 | 30 | 0 |
| K160945 | Endophys Blood Pressure Monitor | Endophys Holdings, LLC | 2016-09-26 | 174 | 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