Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Iriderm Div. — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
164 daysmedian FDA review time
979 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K964074 | DIOLITE 532 | Iriderm Div. | 1997-04-01 | 172 | 0 |
| K960971 | OCULIGHT GL | Iriderm Div. | 1996-08-28 | 170 | 0 |
| K960522 | DIOPEXY PROBE | Iriderm Div. | 1996-07-19 | 164 | 0 |
| K915236 | IRIS G-PROBE | Iriderm Div. | 1994-07-28 | 979 | 0 |
| K933211 | D'AMICO\PEYMAN FLUTED ENDOPROBE | Iriderm Div. | 1994-04-19 | 350 | 0 |
| K922663 | IRIS OCULIGHT SL | Iriderm Div. | 1992-08-11 | 82 | 0 |
| K913430 | IRIS OCULIGHT(R) SLX | Iriderm Div. | 1991-11-15 | 106 | 0 |
| K912918 | IRIS OCULIGHT DIODE LASER ADDING SLIT LAMP ADAPTER | Iriderm Div. | 1991-08-23 | 51 | 0 |
| K903288 | IRIS OCULIGHT SL DIODE LASER PHOTOCOAG/MODIFIED | Iriderm Div. | 1990-09-24 | 88 | 0 |
| K894841 | IRIS OCULIGHT(TM) SL | Iriderm Div. | 1989-10-05 | 66 | 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