Source document or public record

FDA 510(k) K241586 — PIVO™ Pro Needle-free Blood Collection Device

FDA 510(k) index record K241586. Device: PIVO™ Pro Needle-free Blood Collection Device. Applicant as listed: Becton Dickinson Infusion Therapy Systems, Inc.. Decision date: 2025-02-27.

OtherU.S. Food and Drug Administration (FDA)2025-02-27

Source

"device_name": "PIVO™ Pro Needle-free Blood Collection Device"

This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.

Review and references

Reviewer

Automated FDA record verification

Published

2026-10-20

Updated

2026-10-20

Disclaimer

professional use

FDA 510(k) public index record K241586.

Device name: PIVO™ Pro Needle-free Blood Collection Device. Applicant as listed: Becton Dickinson Infusion Therapy Systems, Inc..

Decision date: 2025-02-27. Decision wording: Substantially Equivalent.

Product code: JKA. Regulation: 21 CFR 862.1675. Medical specialty: Clinical Chemistry.

This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.

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