Atlas FDA

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

Mediflex Intl. — Predicate Candidate Screening

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

55 daysmedian FDA review time
90 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K915140PRIMARY DRESSING TRAYMediflex Intl.1992-02-11900
K900841HEMODIALYSIS TRANSDUCER PROTECTORMediflex Intl.1990-05-15820
K891077MEDIVERSE PARENTERAL NUTRITION BAGMediflex Intl.1989-05-24840
K884243BLOOD TUBING SETMediflex Intl.1988-12-08580
K863496MEDIFLEX TRANSDUCER PROTECTORMediflex Intl.1986-09-23140
K855039MEDIFLEX INJECTION CAPMediflex Intl.1986-01-24380
K854346MEDIFLEX DISPOSABLE TUBING CLAMPMediflex Intl.1985-11-18200
K852106I.V. ADMINISTRATION SETMediflex Intl.1985-06-07230
K843126MEDIFLEX DRAINAGE BAGMediflex Intl.1984-10-04550

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