Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Microsurgical Technology, Inc. — Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
73 daysmedian FDA review time
193 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K953959 | PHACO HANDPIECE FOR PHACO FRAGMENTATION MACHINES, PHACO SLEE | Microsurgical Technology, Inc. | 1995-11-17 | 87 | 0 |
| K946194 | WEE BAG O'MERCURY | Microsurgical Technology, Inc. | 1995-02-27 | 69 | 0 |
| K943672 | PHACO NEEDLES AND TIPS | Microsurgical Technology, Inc. | 1994-10-13 | 79 | 0 |
| K942403 | INFUSION CANNULA | Microsurgical Technology, Inc. | 1994-08-17 | 90 | 0 |
| K934844 | INTER TIP T | Microsurgical Technology, Inc. | 1994-04-19 | 193 | 0 |
| K854402 | THE NEW MCINTYRE I.A. HANDPIECE | Microsurgical Technology, Inc. | 1985-12-30 | 60 | 0 |
| K854401 | THE NEW MOBILE TIP MCINTYRE CANNULA | Microsurgical Technology, Inc. | 1985-12-30 | 60 | 0 |
| K853777 | THE NEW MCINTYRE CANNULA | Microsurgical Technology, Inc. | 1985-11-21 | 73 | 0 |
| K840442 | STERILIZED DISPOS. CYSTOTOME | Microsurgical Technology, Inc. | 1984-03-16 | 44 | 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