Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LXQ — Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
82 daysmedian FDA review time
221 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K151575 | Dynarex Eye Cups | Dynarex Corporation | 2015-09-01 | 82 | 0 |
| K140409 | FLENTS PLASTIC EYE WASH CUP | Apothecary Products, Inc. | 2014-07-09 | 141 | 0 |
| K051414 | EYE CUP, STERILE 1 AND NON STERILE | Tollot Pty.Ltd.(Aaxis Pacific) | 2005-06-16 | 16 | 0 |
| K971134 | VISTA EYESHOWER | John Branch | 1997-11-04 | 221 | 0 |
| K881369 | ADVANCE DIAGNOSTICS DISPOSABLE EYECUP | Advantage Diagnostics Corp. | 1988-05-13 | 42 | 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