Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Barosense, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
237 daysmedian FDA review time
662 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K120126 | BAROSENSE ENDOGASTRIC TUBE AND INTRODUCER BOUGIE | Barosense, Inc. | 2012-09-10 | 237 | 0 |
| K120147 | ACE STAPLER AND CARTRIDGE | Barosense, Inc. | 2012-02-17 | 30 | 0 |
| K110829 | ACE STAPLER AND CARTRIDGE | Barosense, Inc. | 2011-06-03 | 71 | 0 |
| K082044 | ACE STAPLER, MODEL F0031 | Barosense, Inc. | 2010-05-11 | 662 | 0 |
| K082589 | BAROSENSE ENDOGASTRIC TUBE (EGT), MODEL F0034 | Barosense, Inc. | 2009-05-22 | 256 | 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