Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
MRX — Predicate Candidate Screening
11 FDA 510(k) clearances under this product code; the 50 most recent screened below.
240 daysmedian FDA review time
326 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253333 | Assisted Reproduction Laser System (Model ILS-400M) | Hua Yue Medical Technology Co., Ltd. | 2026-06-17 | 260 | 0 |
| K202241 | LYKOS Assisted Reproduction Laser with Dynamic Targeting Sys | Hamilton Thorne, Inc. | 2021-07-02 | 326 | 0 |
| K192008 | LaserShot M, NaviLase | Vitrolife GmbH | 2020-03-25 | 240 | 0 |
| K141434 | SATURN 5 LASER | Research Instruments , Ltd. | 2015-02-18 | 264 | 0 |
| K120055 | HANILTON THORNE INFRARED LASER OPTICAL SYSTEM-ZILOS-TK HAMIL | Hamilton Thorne, Inc. | 2012-04-24 | 106 | 0 |
| K083208 | SATURN ACTIVE LASER SYSTEM | Research Instruments , Ltd. | 2009-08-25 | 298 | 0 |
| K063636 | ZILOS-TK | Hamilton Thorne Biosciences | 2007-04-24 | 138 | 0 |
| K060764 | SATURN 3 LASER SYSTEM | Research Instruments , Ltd. | 2007-03-12 | 356 | 0 |
| K062524 | OCTAX LASER SHOT SYSTEM | Minitube of America, Inc. | 2006-12-15 | 109 | 0 |
| K050768 | ZILOS-TK, VERSION 3, ZILOS-TK, VERSION 4 | Hamilton Thorne Biosciences | 2005-04-28 | 34 | 0 |
| DEN040009 | HAMILTON THORNE ZONA INFRARED LASER OPTICAL SYSTEM (ZILOS TK | Hamilton Thorne Biosciences | 2004-11-04 | 71 | 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