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Autofuser

by Ace Medical Us, LLC

510(k) K060258

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

46 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 NumberK060258 Date30 May 2006ClearedStatusActive

Recalls

46 recalls · FDA

  • 45 recalls, same reason

    • Terminated Z-1859-2009 FDA Unclassified (pre-2012) initiated 14 May 2009
    • Terminated Z-1857-2009 FDA Unclassified (pre-2012) initiated 14 May 2009
    • Terminated Z-1836-2009 FDA Unclassified (pre-2012) initiated 14 May 2009
    • Terminated Z-1825-2009 FDA Unclassified (pre-2012) initiated 14 May 2009
    • Terminated Z-1864-2009 FDA Unclassified (pre-2012) initiated 14 May 2009
    • Terminated Z-1837-2009 FDA Unclassified (pre-2012) initiated 14 May 2009
    • Terminated Z-1854-2009 FDA Unclassified (pre-2012) initiated 14 May 2009
    • Terminated Z-1855-2009 FDA Unclassified (pre-2012) initiated 14 May 2009
    • Terminated Z-1862-2009 FDA Unclassified (pre-2012) initiated 14 May 2009
    • Terminated Z-1841-2009 FDA Unclassified (pre-2012) initiated 14 May 2009
    • Terminated Z-1867-2009 FDA Unclassified (pre-2012) initiated 14 May 2009
    • Terminated Z-1829-2009 FDA Unclassified (pre-2012) initiated 14 May 2009
    • Terminated Z-1847-2009 FDA Unclassified (pre-2012) initiated 14 May 2009
    • Terminated Z-1839-2009 FDA Unclassified (pre-2012) initiated 14 May 2009
    • Terminated Z-1824-2009 FDA Unclassified (pre-2012) initiated 14 May 2009
    • Terminated Z-1830-2009 FDA Unclassified (pre-2012) initiated 14 May 2009
    • Terminated Z-1835-2009 FDA Unclassified (pre-2012) initiated 14 May 2009
    • Terminated Z-1851-2009 FDA Unclassified (pre-2012) initiated 14 May 2009
    • Terminated Z-1863-2009 FDA Unclassified (pre-2012) initiated 14 May 2009
    • Terminated Z-1842-2009 FDA Unclassified (pre-2012) initiated 14 May 2009
    • Terminated Z-1850-2009 FDA Unclassified (pre-2012) initiated 14 May 2009
    • Terminated Z-1844-2009 FDA Unclassified (pre-2012) initiated 14 May 2009
    • Terminated Z-1852-2009 FDA Unclassified (pre-2012) initiated 14 May 2009
    • Terminated Z-1831-2009 FDA Unclassified (pre-2012) initiated 14 May 2009
    • Terminated Z-1845-2009 FDA Unclassified (pre-2012) initiated 14 May 2009
    • Terminated Z-1832-2009 FDA Unclassified (pre-2012) initiated 14 May 2009
    • Terminated Z-1849-2009 FDA Unclassified (pre-2012) initiated 14 May 2009
    • Terminated Z-1861-2009 FDA Unclassified (pre-2012) initiated 14 May 2009
    • Terminated Z-1838-2009 FDA Unclassified (pre-2012) initiated 14 May 2009
    • Terminated Z-1866-2009 FDA Unclassified (pre-2012) initiated 14 May 2009
    • Terminated Z-1846-2009 FDA Unclassified (pre-2012) initiated 14 May 2009
    • Terminated Z-1840-2009 FDA Unclassified (pre-2012) initiated 14 May 2009
    • Terminated Z-1827-2009 FDA Unclassified (pre-2012) initiated 14 May 2009
    • Terminated Z-1826-2009 FDA Unclassified (pre-2012) initiated 14 May 2009
    • Terminated Z-1853-2009 FDA Unclassified (pre-2012) initiated 14 May 2009
    • Terminated Z-1856-2009 FDA Unclassified (pre-2012) initiated 14 May 2009
    • Terminated Z-1823-2009 FDA Unclassified (pre-2012) initiated 14 May 2009
    • Terminated Z-1828-2009 FDA Unclassified (pre-2012) initiated 14 May 2009
    • Terminated Z-1868-2009 FDA Unclassified (pre-2012) initiated 14 May 2009
    • Terminated Z-1843-2009 FDA Unclassified (pre-2012) initiated 14 May 2009
    • Terminated Z-1858-2009 FDA Unclassified (pre-2012) initiated 14 May 2009
    • Terminated Z-1833-2009 FDA Unclassified (pre-2012) initiated 14 May 2009
    • Terminated Z-1865-2009 FDA Unclassified (pre-2012) initiated 14 May 2009
    • Terminated Z-1860-2009 FDA Unclassified (pre-2012) initiated 14 May 2009
    • Terminated Z-1834-2009 FDA Unclassified (pre-2012) initiated 14 May 2009

    Failure to infuse and potential compromised sterility: The seal on the tyvek tray cover may fail, compromising sterility, and the device may fail to infuse the drug, resulting in a loss of pain mitigation.

    • Terminated Z-1848-2009 FDA Unclassified (pre-2012) initiated 14 May 2009

    TFailure to infuse and potential compromised sterility: he seal on the tyvek tray cover may fail, compromising sterility, and the device may fail to infuse the drug, resulting in a loss of pain mitigation.

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
MEB
Device Class
Class II
Regulation
21 CFR Part 880.5725
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

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