Atlas FDA

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

Jon-Ko Products, Inc. — Predicate Candidate Screening

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

312 daysmedian FDA review time
313 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K943419ORTHODONTIC ELASTOMERIC LAGATURE MODULEJon-Ko Products, Inc.1995-05-243130
K943421ORTHODONITC ELASTOMERIC SLEEVINGJon-Ko Products, Inc.1995-05-233120
K943420ORTHODONTIC ELASTOMERIC CHAINJon-Ko Products, Inc.1995-05-233120
K943418ORTHODONTIC ELASTOMERIC SEPARATOR MODULEJon-Ko Products, Inc.1995-05-233120
K943417ORTHODONTIC ELASTOMERIC TUBE/THREADJon-Ko Products, Inc.1995-05-233120

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