Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Crospon, Ltd. — Predicate Candidate Screening
12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
107 daysmedian FDA review time
148 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K183072 | EndoFLIP System | Crospon, Ltd. | 2019-02-15 | 102 | 1 |
| K172128 | EsoFLIP® ES-310 Balloon Catheter | Crospon, Ltd. | 2017-11-22 | 131 | 0 |
| K170833 | EndoFLIP® System with FLIP Topography module | Crospon, Ltd. | 2017-04-17 | 28 | 0 |
| K160725 | EndoFLIP | Crospon, Ltd. | 2016-05-01 | 46 | 0 |
| K142000 | ESOFLIP ES | Crospon, Ltd. | 2014-09-25 | 64 | 0 |
| K132337 | ESOFLIP BALLOON DILATION CATHETER | Crospon, Ltd. | 2013-10-07 | 73 | 1 |
| K130906 | ENDOFLIP CATHETER | Crospon, Ltd. | 2013-07-17 | 107 | 0 |
| K120997 | BAROSTAT SOFTWARE OPTION | Crospon, Ltd. | 2012-08-27 | 147 | 0 |
| K110531 | ENDOFLIP ECD | Crospon, Ltd. | 2011-10-06 | 224 | 0 |
| K110529 | ENDOFLIP GASTRIC TUBE | Crospon, Ltd. | 2011-07-22 | 148 | 0 |
| K102214 | ENDO FLIP | Crospon, Ltd. | 2010-12-16 | 132 | 0 |
| K092850 | ENDOFLIP | Crospon, Ltd. | 2009-12-15 | 90 | 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