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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-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K953959PHACO HANDPIECE FOR PHACO FRAGMENTATION MACHINES, PHACO SLEEMicrosurgical Technology, Inc.1995-11-17870
K946194WEE BAG O'MERCURYMicrosurgical Technology, Inc.1995-02-27690
K943672PHACO NEEDLES AND TIPSMicrosurgical Technology, Inc.1994-10-13790
K942403INFUSION CANNULAMicrosurgical Technology, Inc.1994-08-17900
K934844INTER TIP TMicrosurgical Technology, Inc.1994-04-191930
K854402THE NEW MCINTYRE I.A. HANDPIECEMicrosurgical Technology, Inc.1985-12-30600
K854401THE NEW MOBILE TIP MCINTYRE CANNULAMicrosurgical Technology, Inc.1985-12-30600
K853777THE NEW MCINTYRE CANNULAMicrosurgical Technology, Inc.1985-11-21730
K840442STERILIZED DISPOS. CYSTOTOMEMicrosurgical Technology, Inc.1984-03-16440

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