Atlas FDA

AUTOFUSER

FDA 510(k) clearance K060258 · decided 2006-05-30

Clearance details

K-number
K060258
Device name
AUTOFUSER
Applicant
Ace Medical Us, LLC
Decision
Substantially Equivalent
Date received
2006-02-01
Decision date
2006-05-30
Days to decision
118 days
Clearance type
Traditional
Product code
MEB
Device class
2
Regulation number
880.5725
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Powell, OH, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Stryker 100 mL AutoFuser PainPump, single site continuous, 1.0 mL/hr, 1 x 2.5" ExFen cathe recall (Z-1823-2009)Stryker Instruments Div. of Stryker Corporation2009-09-04
Stryker 100 mL AutoFuser PainPump, single site continuous, 2.0 mL/hr, sterile, REF 0531-20 recall (Z-1824-2009)Stryker Instruments Div. of Stryker Corporation2009-09-04
Stryker 100 mL AutoFuser PainPump, single site continuous, 2.0 mL/hr, 1 x 2.5" standard ca recall (Z-1825-2009)Stryker Instruments Div. of Stryker Corporation2009-09-04
Stryker 100 mL AutoFuser PainPump, single site continuous, 2 mL/hr, 1 x 2.5" catheter, ste recall (Z-1826-2009)Stryker Instruments Div. of Stryker Corporation2009-09-04
Stryker 100 mL AutoFuser PainPump, dual site continuous, 2 mL/hr, sterile, REF 0531-200-20 recall (Z-1827-2009)Stryker Instruments Div. of Stryker Corporation2009-09-04
Stryker 100 mL AutoFuser PainPump, dual site continuous, 2 mL/hr, 2 x 2.5 in. catheters, s recall (Z-1828-2009)Stryker Instruments Div. of Stryker Corporation2009-09-04
Stryker 100 mL AutoFuser PainPump, single site continuous, 2 mL/hr, 1 mL bolus, 60 minute recall (Z-1829-2009)Stryker Instruments Div. of Stryker Corporation2009-09-04
Stryker 100 mL AutoFuser PainPump, single site continuous with bolus, 2 mL/hr, 1 mL bolus, recall (Z-1830-2009)Stryker Instruments Div. of Stryker Corporation2009-09-04
Stryker 100 mL AutoFuser PainPump, single site continuous with bolus, 2 mL/hr, 1 mL bolus, recall (Z-1831-2009)Stryker Instruments Div. of Stryker Corporation2009-09-04
Stryker 100 mL AutoFuser PainPump, single site continuous with bolus, 2 mL/hr, 1 mL bolus, recall (Z-1832-2009)Stryker Instruments Div. of Stryker Corporation2009-09-04
Stryker 275 mL AutoFuser PainPump, single site continuous, 2 mL/hr, sterile, REF 0532-200- recall (Z-1833-2009)Stryker Instruments Div. of Stryker Corporation2009-09-04
Stryker 275 mL AutoFuser PainPump, single site continuous, 2 mL/hr,standard catheter, ster recall (Z-1834-2009)Stryker Instruments Div. of Stryker Corporation2009-09-04
Stryker 275 mL AutoFuser PainPump, single site continuous, 2 mL/hr, 1 x 2.5 in. catheter, recall (Z-1835-2009)Stryker Instruments Div. of Stryker Corporation2009-09-04
Stryker 275 mL AutoFuser PainPump, single site continuous, 2 mL/hr, 1 x 5.0 in. catheter, recall (Z-1836-2009)Stryker Instruments Div. of Stryker Corporation2009-09-04
Stryker 275 mL AutoFuser PainPump, single site continuous, 2 mL/hr, 2 mL bolus, 60 minute recall (Z-1837-2009)Stryker Instruments Div. of Stryker Corporation2009-09-04
Stryker 275 mL AutoFuser PainPump, single site continuous with bolus, 2 mL/hr, 2 mL bolus, recall (Z-1838-2009)Stryker Instruments Div. of Stryker Corporation2009-09-04
Stryker 275 mL AutoFuser PainPump, single site continuous with bolus, 2 mL/hr, 2 mL bolus, recall (Z-1839-2009)Stryker Instruments Div. of Stryker Corporation2009-09-04
Stryker 275 mL AutoFuser PainPump, dual site continuous, 4 mL/hr, sterile, REF 0532-400-20 recall (Z-1840-2009)Stryker Instruments Div. of Stryker Corporation2009-09-04
Stryker 275 mL AutoFuser PainPump, dual site continuous, 4 mL/hr, 2 x 10 in. catheters, st recall (Z-1841-2009)Stryker Instruments Div. of Stryker Corporation2009-09-04
Stryker 275 mL AutoFuser PainPump, dual site continuous, 4 mL/hr, 2 x 2.5 in. catheter, st recall (Z-1842-2009)Stryker Instruments Div. of Stryker Corporation2009-09-04
Stryker 275 mL AutoFuser PainPump, dual site continuous, 4 mL/hr, 2 x 5.0 in. catheters, s recall (Z-1843-2009)Stryker Instruments Div. of Stryker Corporation2009-09-04
Stryker 275 mL AutoFuser PainPump, single site continuous, 5 mL/hr, sterile, REF 0532-500- recall (Z-1844-2009)Stryker Instruments Div. of Stryker Corporation2009-09-04
Stryker 275 mL AutoFuser PainPump, single site continuous, 5 mL/hr, standard catheter, ste recall (Z-1845-2009)Stryker Instruments Div. of Stryker Corporation2009-09-04
Stryker 275 mL AutoFuser PainPump, single site continuous, 5 mL/hr, 1 x 2.5 in. catheter, recall (Z-1846-2009)Stryker Instruments Div. of Stryker Corporation2009-09-04
Stryker 275 mL AutoFuser PainPump, single site continuous, 5 mL/hr, 1 x 5.0 in. catheter, recall (Z-1847-2009)Stryker Instruments Div. of Stryker Corporation2009-09-04
Stryker 275 mL AutoFuser PainPump, single site continuous, 5 mL/hr, 2 mL bolus, 60 minute recall (Z-1848-2009)Stryker Instruments Div. of Stryker Corporation2009-09-04
Stryker 275 mL AutoFuser PainPump, single site continuous, 5 mL/hr, 2 mL bolus, 60 minute recall (Z-1849-2009)Stryker Instruments Div. of Stryker Corporation2009-09-04
Stryker 275 mL AutoFuser PainPump, single site continuous with bolus, 5 mL/hr, 2 mL bolus, recall (Z-1850-2009)Stryker Instruments Div. of Stryker Corporation2009-09-04
Stryker 550 mL AutoFuser PainPump, single site continuous, 10 mL/hr, sterile, REF 0535-100 recall (Z-1851-2009)Stryker Instruments Div. of Stryker Corporation2009-09-04
Stryker 550 mL AutoFuser PainPump, dual site continuous, 4 mL/hr, sterile, REF 0535-400-20 recall (Z-1852-2009)Stryker Instruments Div. of Stryker Corporation2009-09-04
Stryker 550 mL AutoFuser PainPump, dual site continuous, 4 mL/hr, 2 x 10.0 in. catheters, recall (Z-1853-2009)Stryker Instruments Div. of Stryker Corporation2009-09-04
Stryker 550 mL AutoFuser PainPump, dual site continuous, 4 mL/hr, 2 x 2.5 in. catheters, s recall (Z-1854-2009)Stryker Instruments Div. of Stryker Corporation2009-09-04
Stryker 550 mL AutoFuser PainPump, dual site continuous, 4 mL/hr, 2 x 5.0 in. catheters, s recall (Z-1855-2009)Stryker Instruments Div. of Stryker Corporation2009-09-04
Stryker 550 mL AutoFuser PainPump, single site continuous with bolus, 4 mL/hr, 2 mL bolus, recall (Z-1856-2009)Stryker Instruments Div. of Stryker Corporation2009-09-04
Stryker 550 mL AutoFuser PainPump, single site continuous with bolus, 4 mL/hr, 2 mL bolus, recall (Z-1857-2009)Stryker Instruments Div. of Stryker Corporation2009-09-04
Stryker 550 mL AutoFuser PainPump, single site continuous with bolus, 4 mL/hr, 2 mL bolus, recall (Z-1858-2009)Stryker Instruments Div. of Stryker Corporation2009-09-04
Stryker 550 mL AutoFuser PainPump, single site continuous with bolus, 4 mL/hr, 2 mL bolus, recall (Z-1859-2009)Stryker Instruments Div. of Stryker Corporation2009-09-04
Stryker 550 mL AutoFuser PainPump, single site continuous with bolus, 5 mL/hr, sterile, RE recall (Z-1860-2009)Stryker Instruments Div. of Stryker Corporation2009-09-04
Stryker 550 mL AutoFuser PainPump, single site continuous with bolus, 5 mL/hr, 1 x 10.0 in recall (Z-1861-2009)Stryker Instruments Div. of Stryker Corporation2009-09-04
Stryker 550 mL AutoFuser PainPump, single site continuous with bolus, 5 mL/hr, 1 x 5.0 in. recall (Z-1862-2009)Stryker Instruments Div. of Stryker Corporation2009-09-04
Stryker 550 mL AutoFuser PainPump, single site continuous with bolus, 6 mL/hr, sterile, RE recall (Z-1863-2009)Stryker Instruments Div. of Stryker Corporation2009-09-04
Stryker 550 mL AutoFuser PainPump, single site continuous with bolus, 6 mL/hr, 2 mL bolus, recall (Z-1864-2009)Stryker Instruments Div. of Stryker Corporation2009-09-04
Stryker 550 mL AutoFuser PainPump, single site continuous with bolus, 6 mL/hr, 2 mL bolus, recall (Z-1865-2009)Stryker Instruments Div. of Stryker Corporation2009-09-04
Stryker 550 mL AutoFuser PainPump, single site continuous with bolus, 6 mL/hr, 2 mL bolus, recall (Z-1866-2009)Stryker Instruments Div. of Stryker Corporation2009-09-04
Stryker 550 mL AutoFuser PainPump, single site continuous with bolus, 6 mL/hr, 2 mL bolus, recall (Z-1867-2009)Stryker Instruments Div. of Stryker Corporation2009-09-04
Stryker 100 mL AutoFuser PainPump, single site continuous, 2 mL/hr with 2.5 in. antimicrob recall (Z-1868-2009)Stryker Instruments Div. of Stryker Corporation2009-09-04