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Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Mayaguez Medical Center · Predicate Candidate Screening

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

116 daysmedian FDA review time
122 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K932804IRRIGATING TAPERED PROBEMayaguez Medical Center1993-08-16680
K93280510.0MM SUCTION/IRRIGATION PROBE & TUBING KITMayaguez Medical Center1993-08-16680
K931950POOLE TIP SUCTION PROBEMayaguez Medical Center1993-08-111130
K932806POOLE TIP SUCTION PROBE & TUBING KITMayaguez Medical Center1993-08-11630
K931854ENDOSCOPIC BLUNT DISSECTING INSTRUMENTMayaguez Medical Center1993-08-101190
K9318565.0 MM IRRIGATION/ASPIRATION PROBEMayaguez Medical Center1993-08-101190
K931912IRRIGATING BLUNT DISSECTORMayaguez Medical Center1993-08-101160
K931706ENDOSCOPIC CABLE DRAPEMayaguez Medical Center1993-08-061220
K931707ENDOSCOPIC CABLE/WIRE COVERMayaguez Medical Center1993-08-061220
K931705ENDOSCOPIC INSTRUMENT HOLDERMayaguez Medical Center1993-07-221070

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