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510(k) K253047

PRESSONE™ by Nipro Medical Corporation — Product Code FMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 2026
Date Received
September 22, 2025
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 Corporation

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  • K190037 — Cronus HP PTA Balloon Catheter (October 24, 2019)
  • K191359 — Nipro Syringe (October 9, 2019)
  • K182940 — Surdial DX Hemodialysis System (July 19, 2019)
  • K173029 — Nipro Syringe (March 30, 2018)
  • K161681 — Nipro SafeTouch IV Catheter (March 8, 2017)
  • K160444 — FB-U Hemodialyzer (February 8, 2017)
  • K151141 — Cronus HP - High Pressure Peripheral Balloon Catheter (January 14, 2016)

Other clearances for product code FMI

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  • K252908 — Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen (March 25, 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)
  • 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)