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B-D PEN ULTRA

by Bd Becton Dickinson Vacutainer Systems Preanalytic 510(k)

Active United States

510(k) K981797

Overview

The B-D PEN ULTRA is a blood collection set designed to improve patient comfort and streamline the collection process. It features BD PentaPoint™ and BD RightGauge™ needle technology to enhance vein access and reduce procedure times.

The device is supplied as a single-use, sterile product and is intended for use in blood collection procedures. It is not MRI safe and should be stored in a dry environment. The device has received FDA 510(k) authorization.

AI-generated from registry data, 26 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK981797 Date12 Jun 1998ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
FMF
Device Class
Class II
Regulation
21 CFR Part 880.5860
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

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Questions

  • What technology does the B-D PEN ULTRA use to improve blood collection?

    The B-D PEN ULTRA utilizes BD PentaPoint™ and BD RightGauge™ needle technology. These features are designed to enhance vein access and reduce the time required for the procedure.

  • Is the B-D PEN ULTRA intended for single use?

    Yes, the B-D PEN ULTRA is supplied as a single-use, sterile product. It is intended for use in blood collection procedures and should not be reused.

  • How should the B-D PEN ULTRA be stored?

    The device should be stored in a dry environment to maintain its sterility and functionality until it is ready for use.

  • Is the B-D PEN ULTRA safe for use in an MRI environment?

    No, the B-D PEN ULTRA is not MRI safe. It should not be used in an MRI environment.