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

Geneva Laboratories, Inc. — Predicate Candidate Screening

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

77 daysmedian FDA review time
181 days90th percentile
13clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K881217GENT-L-KARE STERILE URINARY LEG BAGGeneva Laboratories, Inc.1988-07-291290
K881213GENT-L-KARE STERILE URINARY DRAINAGE BAG CENTERGeneva Laboratories, Inc.1988-07-281290
K881218GENT-L-KARE CLEANSING ENEMA SETGeneva Laboratories, Inc.1988-07-281280
K881216GENT-L-KARE VAGINAL IRRIGATION SETGeneva Laboratories, Inc.1988-06-07770
K861308ACCUPAC CUSTOM PACK KERLIX SQUARESGeneva Laboratories, Inc.1986-05-02240
K861219ACCUPAC CUSTOM SKIN SCRUB KITGeneva Laboratories, Inc.1986-04-15140
K853265ACCUPAC CUSTOM OPERATING ROOM PROCEDURE-DK876543Geneva Laboratories, Inc.1985-08-26210
K843206COOK COUNTY HOSPITAL DRESSING CHANGE SETGeneva Laboratories, Inc.1985-05-242820
K844255GENT-L-KARE STERILE I.V. START KITGeneva Laboratories, Inc.1984-12-19470
K843090UNIVERSITY OF CHICAGO VASCULAR ANGIOGRAMGeneva Laboratories, Inc.1984-12-041200
K830725GENT-L-SPEC DISPOS. VAGINAL SPECULUMGeneva Laboratories, Inc.1983-04-27500
K822735SURE-COUNT DISPOSABLE NEEDLE COUNTERGeneva Laboratories, Inc.1983-03-091810
K802940SUPER-SPIKE TRANSFER SETGeneva Laboratories, Inc.1981-01-15570

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