Atlas FDA

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

Scientific Distributors, Inc. — Predicate Candidate Screening

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

41 daysmedian FDA review time
94 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K892658SDI PREPAX COUNTAPETTE KITScientific Distributors, Inc.1989-05-24410
K851320SDI PREPAX DILUKIT M.Scientific Distributors, Inc.1985-07-05940
K840044SDI PREPAX DILUKIT 29-1000Scientific Distributors, Inc.1984-03-09630
K840041SDI PREPAX DILUKIT HWScientific Distributors, Inc.1984-03-05590
K840042SDI PREPAX DILUKIT CAScientific Distributors, Inc.1984-02-10350
K840038PREPAX DILUKIT PLUSScientific Distributors, Inc.1984-02-10360
K840043SDI PREPAX DILUKIT CTScientific Distributors, Inc.1984-02-10350

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