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IV Administration Set with Backcheck

by National Patent Development Corp.

510(k) K790062

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

56 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 NumberK790062 Date10 Apr 1979ClearedStatusActive

Recalls

61 recalls · 56 ongoing · FDA

  • 56 recalls, same reason

    • Ongoing Z-0703-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0682-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0657-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0683-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0698-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0668-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0653-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0694-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0665-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0696-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0692-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0656-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0604-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0625-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0699-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0686-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0662-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0688-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0695-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0689-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0612-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0659-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0624-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0671-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0610-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0663-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0607-2026 FDA Class II initiated 29 Oct 2025 on shared 510(k) K790062
    • Ongoing Z-0627-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0691-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0614-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0672-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0666-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0704-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0684-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0652-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0690-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0603-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0718-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0661-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0615-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0658-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0631-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0660-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0626-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0693-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0667-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0697-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0687-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0664-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0613-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0715-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0676-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0654-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0674-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0685-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0609-2026 FDA Class II initiated 29 Oct 2025

    Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

  • 2 recalls, same reason

    • Terminated Z-1433-2009 FDA Unclassified (pre-2012) initiated 27 Mar 2009
    • Terminated Z-1434-2009 FDA Unclassified (pre-2012) initiated 27 Mar 2009

    Device defect is occlusion/no flow.

  • 2 recalls, same reason

    • Terminated Z-2413-2008 FDA Unclassified (pre-2012) initiated 30 Jun 2008
    • Terminated Z-2412-2008 FDA Unclassified (pre-2012) initiated 30 Jun 2008

    incorrect burette was packaged with the product

    • Terminated Z-0933-03 FDA Unclassified (pre-2012) initiated 14 Apr 2003

    possible leakage

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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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