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

Electromek Diagnostic Systems, Inc. — Predicate Candidate Screening

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

134 daysmedian FDA review time
183 days90th percentile
11clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K902986G.E. DXD 325/350/350II/DXD 525/525II GENERATORSElectromek Diagnostic Systems, Inc.1991-02-132320
K902987G.E. DXS 350/550/650/650II SINGLE PHASE GENERATORSElectromek Diagnostic Systems, Inc.1990-12-261830
K902985G.E. MST 625/625II/MST 1050/1050II THREE PHASE GENElectromek Diagnostic Systems, Inc.1990-12-191760
K902988G.E. MSI 850/850II/1250 THREE PHASE GENERATORSElectromek Diagnostic Systems, Inc.1990-12-191760
K902982G.E. POLARIX II C-ARMElectromek Diagnostic Systems, Inc.1990-11-131400
K902981G.E. FLUOROCON 300 IMAGING SYSTEMElectromek Diagnostic Systems, Inc.1990-11-071340
K902983SIEMEN'S SIREMOBILE II C-ARMElectromek Diagnostic Systems, Inc.1990-11-061330
K902791G.E. 48-4 CEILING TUBEHANGERElectromek Diagnostic Systems, Inc.1990-10-291250
K902989G.E. MONITROL 90 AND G.E. MONITROL 15Electromek Diagnostic Systems, Inc.1990-10-291250
K902984G.E. AMX 110, AMX II AND AMX 3 X-RAY UNITSElectromek Diagnostic Systems, Inc.1990-10-261220
K902980G.E. XT CEILING TUBE SUSPENSIONElectromek Diagnostic Systems, Inc.1990-10-231190

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