Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Mira, Inc. — Predicate Candidate Screening
21 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
71 daysmedian FDA review time
251 days90th percentile
21clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K951728 | SCHEPENS-YOSHIDA VIDEO BINOCULAR INDIRECT OPHTHALMSCOPE | Mira, Inc. | 1997-03-19 | 706 | 0 |
| K950806 | SOLID DILICONE IMPLANTS, SDILICONE SPONGE IMPLANTS | Mira, Inc. | 1996-06-05 | 469 | 0 |
| K941495 | RETURN PATH DIATHERMY HANDLE | Mira, Inc. | 1994-07-15 | 109 | 0 |
| K933527 | MODIFICATION OF ANTERIOR SEGMENT ELECTRODES | Mira, Inc. | 1994-01-25 | 189 | 0 |
| K923629 | OPHTHALMIC TRICHIASIS PROBE | Mira, Inc. | 1992-10-19 | 90 | 0 |
| K894248 | CONVERTER SYSTEM | Mira, Inc. | 1990-02-27 | 251 | 0 |
| K891601 | POWER OPERATED AND CONTROLLED VITREOUS SCISSORS | Mira, Inc. | 1989-05-23 | 64 | 0 |
| K890448 | LIGHT SOURCE, ENDOSCOP, XENON ARC | Mira, Inc. | 1989-05-08 | 101 | 0 |
| K863246 | MIRALITE | Mira, Inc. | 1986-10-31 | 70 | 0 |
| K863591 | ENDOPHOTOCOAGULATION PROBE | Mira, Inc. | 1986-10-10 | 25 | 0 |
| K855105 | SIMMONS SHELL | Mira, Inc. | 1986-03-31 | 98 | 0 |
| K854869 | INTRAOCULAR FORCEPS & SCISSORS | Mira, Inc. | 1986-03-05 | 91 | 0 |
| K855215 | AIR/FLUID EXCHANGE SYSTEM | Mira, Inc. | 1986-02-27 | 59 | 0 |
| K854870 | INTRAOCULAR ELECTROMAGNET | Mira, Inc. | 1986-02-19 | 77 | 0 |
| K854872 | VFI/VFE SYSTEM II | Mira, Inc. | 1986-02-13 | 71 | 0 |
| K854871 | MICRO SURGICAL SYSTEM | Mira, Inc. | 1986-02-07 | 65 | 0 |
| K854868 | I/A - VFE SYSTEM II | Mira, Inc. | 1986-02-07 | 65 | 0 |
| K854873 | INTRAOCULAR PRESSURE REDUCER | Mira, Inc. | 1986-02-04 | 62 | 0 |
| K853890 | OPHTHALMIC LASER PHOTOCOAGULATOR | Mira, Inc. | 1985-11-12 | 54 | 0 |
| K854288 | OPHALMIC LASER PHOTOCOAGULATOR | Mira, Inc. | 1985-11-12 | 18 | 0 |
| K843345 | AGL400 ARGON LASER SYSTEM-KRL500 KRYPTON | Mira, Inc. | 1984-11-06 | 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