Home / 510(k) Clearances / K914475

510(k) K914475

IV START KIT by Cypress Medical Products, Ltd. — Product Code LRS

K914475 is an FDA 510(k) premarket notification submitted by Cypress Medical Products, Ltd. for the device "IV START KIT". The FDA issued a decision of Substantially Equivalent (kit, denovo) on March 18, 1992. The device falls under product code LRS (I.V. Start Kit), a Class II device regulated under 21 CFR 880.5200. Cypress Medical Products, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SEKD (Substantially Equivalent (kit, denovo))
Decision Date
March 18, 1992
Date Received
October 8, 1991
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 Cypress Medical Products, Ltd.

  • K021676 — CYPRESS MEDICAL PRODUCTS, LP DISPOSABLE VAGINAL SPECULUM, NON-METAL (July 12, 2002)
  • K012282 — STERILE POWDER FREE SYNTHETIC VINYL PATIENT EXAM GLOVE (August 6, 2001)
  • K972899 — CYPRESS MEDICAL PRODUCTS ANEROID SPHYGMOMANOMETER (July 7, 1998)
  • K972849 — ISOSAFE EARLOOP PROCEDURE MASK (BLUE, YELLOW) (May 28, 1998)
  • K972883 — ISOSAFE EARLOOP PROCEDURE MASK (BLUE, YELLOW) (February 26, 1998)
  • K952367 — CYPRESS MEDICAL PRODUCTS VINYL EXAMINATION GLOVE (July 5, 1995)
  • K950254 — CYPRESS MEDICAL PRODUCTS STERILE LATEX EXAMINATION GLOVE (March 31, 1995)
  • K950092 — CYPRESS MEDICAL PRODUCTS CATHETER (INSERTION) TRAY (February 27, 1995)
  • K950109 — CYPRESS MEDICAL PRODUCTS CATHETER (INSERTION) TRAY/WITH OUT CATHETER (February 27, 1995)
  • K945082 — CYPRESS MEDICAL PRODUCTS STETHOSCOPE (December 8, 1994)

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