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Intravenous Extension Set

by Medical Product Specialists

510(k) K895367

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK895367 Date6 Oct 1989ClearedStatusActive

Recalls

6 recalls · 1 ongoing · FDA

    • Ongoing Z-2645-2026 FDA Class II initiated 5 Jun 2026

    May contain incorrect connectors and will not attach or misconnect to ENFit connections and is thus incompatible. Issue could lead to slight delay in delivery of enteral nutritional fluids or oral medication.

  • 5 recalls, same reason

    • Terminated Z-1076-2010 FDA Unclassified (pre-2012) initiated 18 Dec 2009
    • Terminated Z-1077-2010 FDA Unclassified (pre-2012) initiated 18 Dec 2009
    • Terminated Z-1078-2010 FDA Unclassified (pre-2012) initiated 18 Dec 2009
    • Terminated Z-1079-2010 FDA Unclassified (pre-2012) initiated 18 Dec 2009
    • Terminated Z-1080-2010 FDA Unclassified (pre-2012) initiated 18 Dec 2009

    Some lots of IV Extension Sets with BD Q-Syte Luer Access Split Septum have a manufacturing deviation which could cause the product to not function properly, possibly resulting in an air embolism.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FPA
Device Class
Class II
Regulation
21 CFR Part 880.5440
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

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