FDA 510(k) clearance · back to tracker
BD Saf-T-Intima Subcutaneous Catheter System
Becton Dickinson Infusion Therapy Systems, Inc. cleared K251422 on 2025-10-08, decision: substantially equivalent
K-number
K251422
Sponsor
Becton Dickinson Infusion Therapy Systems, Inc.
Device
BD Saf-T-Intima Subcutaneous Catheter System
Class
Class II
Decision
Substantially Equivalent
Decision date
2025-10-08
Product code
FOZ
Advisory committee
General Hospital
Medical specialty
General Hospital
Regulation number
880.5200
Official FDA record
Open K251422on accessdata.fda.gov →
FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.
openFDA JSON
Raw record →
Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.
Use this as a predicate
Drop K251422 into Compass and start a substantial-equivalence draft.
Compass pulls the predicate's intended use, technological characteristics, and performance data, maps them against your device, and produces a draft SE table aligned to FDA's 510(k) program guidance.
Try the sandboxSource
Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.