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

Gorman Rupp Industries — Predicate Candidate Screening

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

26 daysmedian FDA review time
50 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K771537AQUAMATIC K-MODULE MODEL K-20Gorman Rupp Industries1977-09-06260
K770839AQUAMATIC K-77Gorman Rupp Industries1977-06-08300
K770232BLOOD/FLUID WARMER MODEL DW-1000AGorman Rupp Industries1977-02-1470
K761337AQUAMATIC K-MODULE MODEL K-10Gorman Rupp Industries1977-01-10140
K760910DISPOSABLE K-PADSGorman Rupp Industries1976-12-16500
K761087ELECTRONIC CONTROL UNITGorman Rupp Industries1976-12-06140

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