inforMED
LRSClass II

I.v. Start Kit

General Hospital · 21 CFR 880.5200

This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

MDR events315All time
Recalls162All time
Registered firms74Currently listed
510(k) clearances30All time

Product problems

Reported product problem codes, most common first

Break33
Leak/Splash27
Material Twisted/Bent22
Crack17
Fluid/Blood Leak17
Gas/Air Leak17
Material Integrity Problem14
Component Missing12

Trend for “Break

0510Apr 24Aug 24Dec 24Apr 25Aug 25Dec 25Apr 26

Recalls

162 recall events for this product code

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