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Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Minimally Invasive Surgical Technologies, Inc. · Predicate Candidate Screening

6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

150 daysmedian FDA review time
156 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K951398MIST REDUCER SLEEVESMinimally Invasive Surgical Technologies, Inc.1995-05-03360
K931273MIST FORCEPS/CLAMPS FOR LAPAROSCOPOIC/ENDOSCOPICMinimally Invasive Surgical Technologies, Inc.1993-08-111560
K931275MIST MICROSURGICAL MONOPOLAR FORCEPSMinimally Invasive Surgical Technologies, Inc.1993-08-051500
K931274MIST MICROSURGICAL MONOPOLAR SCISSORSMinimally Invasive Surgical Technologies, Inc.1993-08-051500
K931272MIST SCISSORS FOR LAPAROSCOPIC/ENDOSCOPIC PROCEDURMinimally Invasive Surgical Technologies, Inc.1993-05-17700
K931276MIST RATCHETED FORCEPS FOR LAPAROSCOPIC/ENDOSCOPICMinimally Invasive Surgical Technologies, Inc.1993-05-13660

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