Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Pluromed, Inc. — 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) |
|---|---|---|---|---|---|
| K110491 | BACKSTOP CATHETER | Pluromed, Inc. | 2011-03-16 | 22 | 0 |
| K103349 | BACKSTOP CATHETER | Pluromed, Inc. | 2011-01-07 | 52 | 0 |
| K090430 | BACKSTOP AND BACKSTOP INJECTOR | Pluromed, Inc. | 2009-06-02 | 103 | 0 |
| K090270 | BACKSTOP CATHETER, MODEL 60-0000-3100 | Pluromed, Inc. | 2009-05-15 | 100 | 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