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FDA 510(k)

BD Preset™ and BD A-Line™ Arterial Blood Collection Syringes

K-Number: K260128 · 2026-04-15

Decision Date2026-04-15
Product CodeJKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BD Preset™ and BD A-Line™ Arterial Blood Collection Syringes is a medical device manufactured by Becton, Dickinson and Company. It received FDA 510(k) clearance on 2026-04-15 under approval number K260128. The device is classified under product code JKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BD Preset™ and BD A-Line™ Arterial Blood Collection Syringes?

BD Preset™ and BD A-Line™ Arterial Blood Collection Syringes is a medical device that received FDA 510(k) clearance on 2026-04-15. It is manufactured by Becton, Dickinson and Company. The 510(k) number is K260128.

When was BD Preset™ and BD A-Line™ Arterial Blood Collection Syringes approved by the FDA?

BD Preset™ and BD A-Line™ Arterial Blood Collection Syringes received FDA 510(k) clearance on 2026-04-15, under approval number K260128.

What company makes BD Preset™ and BD A-Line™ Arterial Blood Collection Syringes?

BD Preset™ and BD A-Line™ Arterial Blood Collection Syringes is manufactured by Becton, Dickinson and Company.

What is the FDA product code for BD Preset™ and BD A-Line™ Arterial Blood Collection Syringes?

The FDA product code for BD Preset™ and BD A-Line™ Arterial Blood Collection Syringes is JKA.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.