Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
NYL · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
112 daysmedian FDA review time
280 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K211721 | PS System | Inter-Med, Inc. | 2021-12-02 | 181 | 0 |
| K162436 | EndoVac Pure | Kerr Corporation | 2016-12-21 | 112 | 0 |
| K140685 | ENDO VAC APICAL NEGATIVE PRESSURE IRIGATION SYSTEM | Sybron Endo | 2014-07-02 | 106 | 0 |
| K100606 | VATEA ENDONTIC IRRIGATION SYSTEM | Redent Nova, Ltd. | 2010-05-28 | 86 | 0 |
| K052271 | RINSENDO | Air Techniques, Inc. | 2006-05-26 | 280 | 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