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

Summit World Trade Corp. · Predicate Candidate Screening

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

57 daysmedian FDA review time
169 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K905833MRP-5000(1): 2-D INFLOW MR ANGIOGRAPHYSummit World Trade Corp.1991-02-25560
K905832MRP -5000(1): VERSION 2.0 SOFTWARESummit World Trade Corp.1991-02-25560
K905834MRP-7000(1) : 2-D INFLOW MR ANGIOGRAPHYSummit World Trade Corp.1991-02-19500
K905835MRP-7000: SUPPLEMENTAL R/F COILSSummit World Trade Corp.1991-02-19500
K903318MAGNETIC RESONANCE DIAGNOSTIC DEVICE MOBILE MRP-30Summit World Trade Corp.1990-11-201180
K903203MRP-20: HS/MR HEAD COIL 3-D FT RECONSTRUCTIONSummit World Trade Corp.1990-09-17590
K903204MRP-20: SUPPL R/F COIL HS/MR QUADRATURE HEAD COILSummit World Trade Corp.1990-09-07490
K901980MOBILE MRP-20 MAGNETIC RESONANCE DIAGNOSTIC DEVICESummit World Trade Corp.1990-06-28570
K900919MODIFIED HITACHI MRP-20 MAGNETIC RESONANCE DIAGNOSSummit World Trade Corp.1990-05-14830
K894016MAGNETIC RESONANCE DIAGNOSTIC DEVICE MRP-20Summit World Trade Corp.1989-11-221690

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