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510(k) K875315

I.V. START KITS by Ni-Med, Inc. — Product Code LRS

K875315 is an FDA 510(k) premarket notification submitted by Ni-Med, Inc. for the device "I.V. START KITS". The FDA issued a decision of Substantially Equivalent (with conditions) on February 17, 1988. The device falls under product code LRS (I.V. Start Kit), a Class II device regulated under 21 CFR 880.5200. Ni-Med, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESD (Substantially Equivalent (with conditions))
Decision Date
February 17, 1988
Date Received
December 29, 1987
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 by Ni-Med, Inc.

  • K981910 — SUCTION CATHETER (August 24, 1998)
  • K872824 — P. URINE METER, 250CC (October 14, 1987)

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)
  • K951167 — EMS I.V. START KIT (May 16, 1995)
  • 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)

FDA data resources