Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Palliare , Ltd. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
217 daysmedian FDA review time
282 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K232902 | EVA15 insufflator | Palliare , Ltd. | 2024-05-02 | 227 | 0 |
| K230474 | EVA5 Insufflator | Palliare , Ltd. | 2023-03-24 | 30 | 0 |
| K222901 | EVA15 insufflator | Palliare , Ltd. | 2023-01-27 | 126 | 0 |
| K202922 | END 200 Endoscopic Tubeset | Palliare , Ltd. | 2021-07-08 | 282 | 0 |
| K202799 | EVA15 | Palliare , Ltd. | 2020-10-21 | 28 | 0 |
| K193520 | EVA 15 Insufflator | Palliare , Ltd. | 2020-07-23 | 217 | 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