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510(k) K852831

NON-KOR ACCESS KITS by Creative Care Systems, Inc. — Product Code FMI

K852831 is an FDA 510(k) premarket notification submitted by Creative Care Systems, Inc. for the device "NON-KOR ACCESS KITS". The FDA issued a decision of Substantially Equivalent (with conditions) on September 19, 1985. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Creative Care Systems, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESD (Substantially Equivalent (with conditions))
Decision Date
September 19, 1985
Date Received
July 2, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Hypodermic, Single Lumen
Device Class
Class II
Regulation Number
880.5570
Review Panel
HO
Submission Type

Other clearances by Creative Care Systems, Inc.

  • K861406 — NON-KOR WINGED INFUSION SETS (May 6, 1986)
  • K850888 — PERCUTANEOUS CV CATHETER INSERTION KIT W OR W/O CV (May 7, 1985)
  • K850887 — DRESSING CHANGE KIT (May 1, 1985)
  • K841742 — NON-CORING NEEDLE (July 6, 1984)
  • K840919 — DAYPAK SYS VII CATHETER CARE KIT (April 17, 1984)
  • K840681 — DAYPAK SYSTEM III CATHETER CARE KIT (April 16, 1984)

Other clearances for product code FMI

  • K260739 — Profoject™ Pen Needles (Model A; Model B) (July 15, 2026)
  • K260855 — Profoject™ Safety Pen Needles (June 10, 2026)
  • K254273 — Verisafe Safety Sterile Needles (SSN) (April 16, 2026)
  • K252908 — Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen (March 25, 2026)
  • K253047 — PRESSONE™ (March 24, 2026)
  • K253622 — Safety Pen Needle (March 18, 2026)
  • K252886 — Pen Needle (January 6, 2026)
  • K250700 — Pen Injector Needle 32.5 (November 21, 2025)
  • K252631 — Profoject™ Disposable Needle (October 16, 2025)
  • K250724 — Intraosseous Infusion Needles (July 30, 2025)

FDA data resources