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Kendall Monoject Pre-Fill Advanced 0.9%SODIUM Chloride Flush Syringes for Sterile Delivery

by Tyco Healthcare/Kendall

510(k) K060339

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

11 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 · Special NumberK060339 Date28 Apr 2006ClearedStatusActive

Recalls

11 recalls · FDA

  • 11 recalls, same reason

    • Terminated Z-2527-2015 FDA Class II initiated 6 Aug 2015
    • Terminated Z-2530-2015 FDA Class II initiated 6 Aug 2015
    • Terminated Z-2526-2015 FDA Class II initiated 6 Aug 2015
    • Terminated Z-2535-2015 FDA Class II initiated 6 Aug 2015
    • Terminated Z-2533-2015 FDA Class II initiated 6 Aug 2015
    • Terminated Z-2531-2015 FDA Class II initiated 6 Aug 2015
    • Terminated Z-2534-2015 FDA Class II initiated 6 Aug 2015
    • Terminated Z-2529-2015 FDA Class II initiated 6 Aug 2015
    • Terminated Z-2525-2015 FDA Class II initiated 6 Aug 2015
    • Terminated Z-2528-2015 FDA Class II initiated 6 Aug 2015
    • Terminated Z-2536-2015 FDA Class II initiated 6 Aug 2015

    Sterility may be compromised

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  • Withdrawn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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