Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ellex Medical Pty, Ltd. · Predicate Candidate Screening
13 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
88 daysmedian FDA review time
321 days90th percentile
13clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K222395 | Tango Neo, Tango Reflex Neo, Ultra Q Reflex Neo | Ellex Medical Pty, Ltd. | 2022-11-02 | 86 | 0 |
| K212630 | Tango, Tango Reflex, Ultra Q, Ultra Q Reflex, Solo | Ellex Medical Pty, Ltd. | 2021-12-16 | 119 | 0 |
| K190786 | Eye Prime | Ellex Medical Pty, Ltd. | 2019-04-11 | 15 | 0 |
| K142398 | Integre Pro Scan Green, Integre Pro Scan Yellow, Integre Pro | Ellex Medical Pty, Ltd. | 2015-07-14 | 321 | 1 |
| K122202 | ELLEX 2RT | Ellex Medical Pty, Ltd. | 2013-07-01 | 341 | 0 |
| K081565 | INTEGRE PRO, MODEL L2RY | Ellex Medical Pty, Ltd. | 2008-07-02 | 28 | 1 |
| K080423 | INTEGRE, MODEL LP581 | Ellex Medical Pty, Ltd. | 2008-03-11 | 25 | 0 |
| K052777 | LASEREX DUO FAMILY OF DUAL WAVELENGTH OPHTHALMIC LASERS INCL | Ellex Medical Pty, Ltd. | 2006-03-16 | 164 | 1 |
| K041598 | LASEREX, MODEL LP4532 | Ellex Medical Pty, Ltd. | 2004-10-06 | 114 | 1 |
| K021550 | LUMENIS SELECTA DUET | Ellex Medical Pty, Ltd. | 2002-08-09 | 88 | 0 |
| K003955 | LASEREX INTEGRE, MODEL LP2532 | Ellex Medical Pty, Ltd. | 2001-03-15 | 84 | 0 |
| K992824 | LASEREX ND:YAG OPHTHALMIC LASER (LQ2106), ALCON ND:YAG OPHTH | Ellex Medical Pty, Ltd. | 1999-11-17 | 86 | 0 |
| K972514 | LASEREX LP1532 PHOTOCOAGULATOR | Ellex Medical Pty, Ltd. | 1997-10-03 | 88 | 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