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510(k) K951167

EMS I.V. START KIT by Emergency Medical Supply, Inc. — Product Code LRS

K951167 is an FDA 510(k) premarket notification submitted by Emergency Medical Supply, Inc. for the device "EMS I.V. START KIT". The FDA issued a decision of SN on May 16, 1995. The device falls under product code LRS (I.V. Start Kit), a Class II device regulated under 21 CFR 880.5200.

Clearance Details

Decision
SN ()
Decision Date
May 16, 1995
Date Received
March 14, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
I.V. Start Kit
Device Class
Class II
Regulation Number
880.5200
Review Panel
SU
Submission Type

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.

Other clearances for product code LRS

  • K050654 — AMSINO I.V. START KIT (May 2, 2005)
  • K001879 — INFUSION IV SET (November 20, 2001)
  • K963722 — IV START KIT (November 27, 1996)
  • K950184 — B. BRAUN IV START KITS (March 15, 1995)
  • K944041 — PERSONAL HEARING SYSTEM (December 27, 1994)
  • K943941 — SAFESTART VASCULAR ACCESS START KIT (October 20, 1994)
  • K935684 — IV START KIT (June 10, 1994)
  • K942238 — I.V. STARTPAK VASCULAR ACCESS START KIT (June 3, 1994)
  • K941469 — IV START KIT (May 12, 1994)
  • K925017 — IV PREP KIT (NON-STERILE) (August 27, 1993)

FDA data resources