Home / 510(k) Clearances / K992699

510(k) K992699

NIPRO BLOOD COLLECTION NEEDLE by Nipro Medical Corp. — Product Code FMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 14, 2000
Date Received
August 12, 1999
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 Nipro Medical Corp.

  • K093985 — NIPRO SAFETOUCH LOCKTAIL SAFETY FISTULA NEEDLE (January 22, 2010)
  • K081210 — NIPRO SAFETOUCH HUBER INFUSTION SET (October 21, 2008)
  • K072024 — NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET, MODEL A201-A21 (October 4, 2007)
  • K063368 — NIPRO BIOHOLE NEEDLE (February 5, 2007)
  • K063721 — NIPRO SAFETOUCH II GAMMA (January 12, 2007)
  • K052474 — NIPRO HYPODERMIC NEEDLE (November 10, 2005)
  • K051574 — NIPRO DISPOSABLE SYRINGE WITH OR WITHOUT NEEDLE (August 26, 2005)
  • K041779 — NIPRO DISPOSABLE STOPCOCKS, MODELS 3W-RC. NCN-3, 3W-R, 3W-L (September 21, 2004)
  • K032777 — MODIFICATION TO: NIPRO SAFE TOUCH SAFETY FISTULA NEEDLE (November 14, 2003)
  • K030683 — NIPRO DISPOSABLE SYRINGES (October 31, 2003)

Other clearances for product code FMI

  • 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)
  • K250284 — TSK SELECT™ Needle (July 24, 2025)
  • K251447 — K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB) (July 8, 2025)
  • K243309 — 27G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT) (May 29, 2025)
  • K240355 — FROG (Filter Removal of Glass) (April 18, 2025)
  • K243581 — K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC) (April 4, 2025)
  • K250658 — SureFine Pen Needle (April 3, 2025)