FDA 510(k) clearance · back to tracker
BD Insyte Autoguard Shielded IV Catheter, BD Insyte Autoguard BC Shielded IV Catheter and BD Insyte Autoguard BC Pro Shielded IV Catheter
Becton Dickinson Infusion Therapy Systems, Inc. cleared K251654 on 2025-06-27, decision: substantially equivalent
K-number
K251654
Sponsor
Becton Dickinson Infusion Therapy Systems, Inc.
Device
BD Insyte Autoguard Shielded IV Catheter, BD Insyte Autoguard BC Shielded IV Catheter and BD Insyte Autoguard BC Pro Shielded IV Catheter
Class
Class II
Decision
Substantially Equivalent
Decision date
2025-06-27
Product code
FOZ
Advisory committee
General Hospital
Medical specialty
General Hospital
Regulation number
880.5200
Official FDA record
Open K251654on 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.
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Drop K251654 into Compass and start a substantial-equivalence draft.
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Try the sandboxSource
Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.