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510(k) K991653

INVISION-PLUS INJECTION PORT CONNECTOR SYSTEM by Rymed Technologies, Inc. — Product Code FPA

K991653 is an FDA 510(k) premarket notification submitted by Rymed Technologies, Inc. for the device "INVISION-PLUS INJECTION PORT CONNECTOR SYSTEM". The FDA issued a decision of Substantially Equivalent on June 24, 1999. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Rymed Technologies, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 1999
Date Received
May 13, 1999
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, Inc.

  • K162826 — Encore Neutral (June 15, 2017)
  • K093489 — IN VISION-PLUS NANO WITH NEUTRAL ADVANTAGE TECHNOLOGY (July 29, 2010)
  • 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