Atlas FDA

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

Kinetic Biomedical Services, Inc. — Predicate Candidate Screening

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

27 daysmedian FDA review time
59 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K892808KINETIC MODEL 700Kinetic Biomedical Services, Inc.1989-06-15590
K891756KINETIC MODEL 500Kinetic Biomedical Services, Inc.1989-04-19270
K891759KINETIC MODEL 330Kinetic Biomedical Services, Inc.1989-04-19270
K891758KINETIC MODEL 132Kinetic Biomedical Services, Inc.1989-04-19270
K891757KINETIC MODEL 1000Kinetic Biomedical Services, Inc.1989-04-19270

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