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0.9% Sodium Chloride Injection Usp Bd Posiflush Flush Syringe, Sf Flush Syringe

by Becton, Dickinson & CO

510(k) K121050

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

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 NumberK121050 Date7 Feb 2013ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-2673-2014 FDA Class II initiated 22 Jul 2014

    BD received some reports of open seals found on the BD Posiflush SF Flush Syringe 10 mL (Ref #306553).

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  • Withdrawn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
NGT
Device Class
Class II
Regulation
21 CFR Part 880.5200
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

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