FDA 510(k) clearance · back to tracker
BD Insyte IV Catheter
Becton Dickinson Infusion Therapy Systems, Inc. cleared K252137 on 2026-04-02, decision: substantially equivalent
K-number
K252137
Sponsor
Becton Dickinson Infusion Therapy Systems, Inc.
Device
BD Insyte IV Catheter
Class
Class II
Decision
Substantially Equivalent
Decision date
2026-04-02
Product code
FOZ
Advisory committee
General Hospital
Medical specialty
General Hospital
Regulation number
880.5200
Official FDA record
Open K252137on accessdata.fda.gov →
FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.
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Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.