Home / 510(k) Clearances / K162826

510(k) K162826

Encore Neutral by Rymed Technologies, LLC — Product Code FPA

K162826 is an FDA 510(k) premarket notification submitted by Rymed Technologies, LLC for the device "Encore Neutral". The FDA issued a decision of Substantially Equivalent on June 15, 2017. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Rymed Technologies, LLC has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 15, 2017
Date Received
October 7, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Administration, Intravascular
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

Other clearances by Rymed Technologies, LLC

  • K093489 — IN VISION-PLUS NANO WITH NEUTRAL ADVANTAGE TECHNOLOGY (July 29, 2010)
  • K991653 — INVISION-PLUS INJECTION PORT CONNECTOR SYSTEM (June 24, 1999)
  • K960771 — SLAV AND SLAV-ONE INJECTION PORT CONNECTOR SYSTEM (December 10, 1996)

Other clearances for product code FPA

  • K254123 — Ecomed Disposable Administration Sets (September 11, 2026)
  • K261530 — iiSure Infusion Set (June 3, 2026)
  • K252543 — AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, (May 4, 2026)
  • K251375 — PuraCath Firefly Needleless Connector IT (9005) (February 12, 2026)
  • K251257 — nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Fre (December 4, 2025)
  • K250325 — BD Alaris Pump Infusion Set (October 30, 2025)
  • K251814 — EZ™ IV Administration Set (August 29, 2025)
  • K251854 — SteadiSet infusion set (August 6, 2025)
  • K243841 — Sparta Infusion Set for Insulin (August 1, 2025)
  • K243392 — Infusomat® Space Volumetric Infusion Pump Administration Sets (July 24, 2025)

FDA data resources