Atlas FDA

PAINPUMP2

FDA 510(k) clearance K043466 · decided 2005-05-10

Clearance details

K-number
K043466
Device name
PAINPUMP2
Applicant
Stryker Instruments
Decision
Substantially Equivalent
Date received
2004-12-15
Decision date
2005-05-10
Days to decision
146 days
Clearance type
Traditional
Product code
FRN
Device class
2
Regulation number
880.5725
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Kalamazoo, MI, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Stryker PainPump2 250 mL Painpump with Luer Lock Tubing Set, REF 525-350, Sterile, Rx only recall (Z-0096-2011)Stryker Instruments Div. of Stryker Corporation2010-10-20
Stryker PainPump2 250 mL PainPump with Luer Lock Tubing Set, sterile, REF 525-350, Stryker recall (Z-2591-2010)Stryker Instruments Div. of Stryker Corporation2010-09-28
Stryker PainPump2 400 mL PainPump with Luer Lock Tubing Set, sterile, REF 540-350, Stryker recall (Z-2592-2010)Stryker Instruments Div. of Stryker Corporation2010-09-28
Stryker PainPump2 BlockAid 400 mL PainPump for Continuous Nerve Block, sterile, REF 575-10 recall (Z-2593-2010)Stryker Instruments Div. of Stryker Corporation2010-09-28
Stryker PainPump2 BlockAid Demo 400 mL PainPump for Continuous Nerve Block, Non-sterile No recall (Z-2594-2010)Stryker Instruments Div. of Stryker Corporation2010-09-28
Stryker PainPump catheter and split introducer needle, sterile, Stryker Instruments, Kalam recall (Z-1736-2009)Stryker Instruments Div. of Stryker Corporation2009-08-19
Stryker ExFen 2.5" extended fenestration catheter set for PainPump, sterile, Stryker Instr recall (Z-1737-2009)Stryker Instruments Div. of Stryker Corporation2009-08-19
Stryker ExFen 5.0" extended fenestration catheter set for PainPump, sterile, Stryker Instr recall (Z-1738-2009)Stryker Instruments Div. of Stryker Corporation2009-08-19
Stryker PainPump base kit, 120 mL infusion kit, sterile, Stryker Instruments, Kalamazoo, M recall (Z-1739-2009)Stryker Instruments Div. of Stryker Corporation2009-08-19
Stryker PainPump, 5-day infusion kit, 120 mL infusion kit (0.83 mL/hr), sterile, Stryker I recall (Z-1740-2009)Stryker Instruments Div. of Stryker Corporation2009-08-19
Stryker PainPump, 2-day infusion kit, 120 mL infusion kit (2.08 mL/hr), sterile, Stryker I recall (Z-1741-2009)Stryker Instruments Div. of Stryker Corporation2009-08-19
Stryker PainPump, 2-day infusion kit with ExFen 2.5", 120 mL infusion kit (2.08 mL/hr), st recall (Z-1742-2009)Stryker Instruments Div. of Stryker Corporation2009-08-19
Stryker PainPump, 2-day infusion kit with ExFen 5.0", 120 mL infusion kit (2.08 mL/hr), st recall (Z-1743-2009)Stryker Instruments Div. of Stryker Corporation2009-08-19
Stryker PainPump, 1-day infusion kit, 120 mL infusion kit (4.16 mL/hr), sterile, Stryker I recall (Z-1744-2009)Stryker Instruments Div. of Stryker Corporation2009-08-19
Stryker PainPump, two site infusion kit with ExFen 2.5", 120 mL infusion kit, sterile, Str recall (Z-1745-2009)Stryker Instruments Div. of Stryker Corporation2009-08-19
Stryker PainPump, two site infusion kit with ExFen 5.0", 120 mL infusion kit, sterile, Str recall (Z-1746-2009)Stryker Instruments Div. of Stryker Corporation2009-08-19
Stryker PainPump, two site infusion set, sterile, Stryker Instruments, Kalamazoo, MI; REF recall (Z-1747-2009)Stryker Instruments Div. of Stryker Corporation2009-08-19
Stryker PainPump, two site infusion set, sterile, Stryker Instruments, Kalamazoo, MI; REF recall (Z-1748-2009)Stryker Instruments Div. of Stryker Corporation2009-08-19
Stryker PainPump, 270 mL base infusion kit, sterile, Stryker Instruments, Kalamazoo, MI; R recall (Z-1749-2009)Stryker Instruments Div. of Stryker Corporation2009-08-19
Stryker PainPump, 270 mL infusion kit (2.08 mL/hr), sterile, Stryker Instruments, Kalamazo recall (Z-1750-2009)Stryker Instruments Div. of Stryker Corporation2009-08-19
Stryker PainPump, 270 mL infusion kit (4.16 mL/hr), sterile, Stryker Instruments, Kalamazo recall (Z-1751-2009)Stryker Instruments Div. of Stryker Corporation2009-08-19
Stryker PainPump, 270 mL infusion kit (4.16 mL/hr) with ExFen 2.5", sterile, Stryker Instr recall (Z-1752-2009)Stryker Instruments Div. of Stryker Corporation2009-08-19
Stryker PainPump, 270 mL infusion kit (2.08 cc/hr) with ExFen 5.0", sterile, Stryker Instr recall (Z-1753-2009)Stryker Instruments Div. of Stryker Corporation2009-08-19
Stryker PainPump, 270 mL two site infusion kit with ExFen 2.5", sterile, Stryker Instrumen recall (Z-1754-2009)Stryker Instruments Div. of Stryker Corporation2009-08-19
Stryker PainPump, 270 mL two site infusion kit with ExFen 5.0", sterile, Stryker Instrumen recall (Z-1755-2009)Stryker Instruments Div. of Stryker Corporation2009-08-19
Stryker PainPump2, 250 mL pre-set PainPump with luer lock tubing set, 2.5 inch ExFen and s recall (Z-1756-2009)Stryker Instruments Div. of Stryker Corporation2009-08-19
Stryker PainPump2, 250 mL pre-set PainPump with luer lock tubing set, 5.0 inch ExFen and s recall (Z-1757-2009)Stryker Instruments Div. of Stryker Corporation2009-08-19
Stryker PainPump ExFen, sterile, Stryker Instruments, Kalamazoo, MI; REF 525-10. recall (Z-1758-2009)Stryker Instruments Div. of Stryker Corporation2009-08-19
Stryker PainPump2, 250 mL PainPump with 2.5 inch ExFen 2-site catheter set, sterile, Stryk recall (Z-1759-2009)Stryker Instruments Div. of Stryker Corporation2009-08-19
Stryker PainPump2, 250 mL PainPump with 5.0 inch ExFen 2-site catheter set, sterile, Stryk recall (Z-1760-2009)Stryker Instruments Div. of Stryker Corporation2009-08-19
Stryker PainPump2, 250 mL PainPump with luer lock tubing set, 2.5 inch ExFen and standard recall (Z-1761-2009)Stryker Instruments Div. of Stryker Corporation2009-08-19
Stryker PainPump2, 250 mL PainPump with luer lock tubing set, 5.0 inch ExFen and standard recall (Z-1762-2009)Stryker Instruments Div. of Stryker Corporation2009-08-19
Stryker PainPump2, 250 mL PainPump with 2.5 inch ExFen catheter and luer lock tubing set, recall (Z-1763-2009)Stryker Instruments Div. of Stryker Corporation2009-08-19
Stryker PainPump2, 2-site tube set with standard catheter, sterile, Stryker Instruments, K recall (Z-1764-2009)Stryker Instruments Div. of Stryker Corporation2009-08-19
Stryker PainPump2, 2-site tube set with 2.5" ExFens, sterile, Stryker Instruments, Kalamaz recall (Z-1765-2009)Stryker Instruments Div. of Stryker Corporation2009-08-19
Stryker PainPump2, 2-site tube set with 5.0" ExFen, sterile, Stryker Instruments, Kalamazo recall (Z-1766-2009)Stryker Instruments Div. of Stryker Corporation2009-08-19
Stryker PainPump2 ExFen 2.5, 2.5" extended fenestration catheter set for PainPump2, steril recall (Z-1767-2009)Stryker Instruments Div. of Stryker Corporation2009-08-19
Stryker PainPump2 ExFen 2.5, 2.5" catheter set for PainPump2, sterile, Stryker Instruments recall (Z-1768-2009)Stryker Instruments Div. of Stryker Corporation2009-08-19
Stryker PainPump2 ExFen 5, 5" extended fenestration catheter set for PainPump2, sterile, S recall (Z-1769-2009)Stryker Instruments Div. of Stryker Corporation2009-08-19
Stryker PainPump2 ExFen 5, 5" catheter set for PainPump2, sterile, Stryker Instruments, Ka recall (Z-1770-2009)Stryker Instruments Div. of Stryker Corporation2009-08-19
Stryker standard catheter set for PainPump2 and AutoFuser PainPump, sterile, Stryker Instr recall (Z-1771-2009)Stryker Instruments Div. of Stryker Corporation2009-08-19
Stryker 5.0 catheter set for PainPump2 and AutoFuser PainPump, sterile, Stryker Instrument recall (Z-1772-2009)Stryker Instruments Div. of Stryker Corporation2009-08-19
Stryker 10.0 catheter set for PainPump2 and AutoFuser PainPump, sterile, Stryker Instrumen recall (Z-1773-2009)Stryker Instruments Div. of Stryker Corporation2009-08-19
Stryker 2.5 catheter set for PainPump2 and AutoFuser PainPump, sterile, Stryker Instrument recall (Z-1774-2009)Stryker Instruments Div. of Stryker Corporation2009-08-19
Stryker 5.0 catheter set for PainPump2 and AutoFuser PainPump, sterile, Stryker Instrument recall (Z-1775-2009)Stryker Instruments Div. of Stryker Corporation2009-08-19
Stryker dual 10.0 catheter set for PainPump2 and AutoFuser PainPump, sterile, Stryker Inst recall (Z-1776-2009)Stryker Instruments Div. of Stryker Corporation2009-08-19
Stryker dual 2.5 catheter set for PainPump2 and AutoFuser PainPump, sterile, Stryker Instr recall (Z-1777-2009)Stryker Instruments Div. of Stryker Corporation2009-08-19
Stryker PainPump2, 400 mL PainPump with 2.5 inch ExFen 2-site catheter set, sterile, Stryk recall (Z-1778-2009)Stryker Instruments Div. of Stryker Corporation2009-08-19
Stryker PainPump2, 400 mL PainPump with 5.0 inch ExFen 2-site catheter set, sterile, Stryk recall (Z-1779-2009)Stryker Instruments Div. of Stryker Corporation2009-08-19
Stryker PainPump2, 400 mL PainPump with luer lock tubing set, 5.0 inch ExFen and standard recall (Z-1780-2009)Stryker Instruments Div. of Stryker Corporation2009-08-19