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510(k) K853255

OMNIMED I.V. SOLUTION ADMIN. SET by Omni Intl., Inc. — Product Code FPA

K853255 is an FDA 510(k) premarket notification submitted by Omni Intl., Inc. for the device "OMNIMED I.V. SOLUTION ADMIN. SET". The FDA issued a decision of Substantially Equivalent on August 23, 1985. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Omni Intl., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 23, 1985
Date Received
August 2, 1985
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 Omni Intl., Inc.

  • K984066 — OMNIGRIP, LATEX SURGICAL GLOVE, POWDER-FREE WITH PROTEIN LABELING CLAIM (January 13, 1999)
  • K984064 — OMNIGRIP, LATEX SURGICAL GLOVE, POWDER FREE (January 8, 1999)
  • K851938 — OMNIMED SURGICAL GOWN (June 28, 1985)
  • K851654 — OMNIMED CLAMP (May 31, 1985)
  • K851734 — OMNIMED SUPERIOR TRANSDUCER PROTECTOR (May 23, 1985)
  • K850706 — F-SERIES IMPLANT (April 10, 1985)
  • K850112 — OMNIMED IV SOLUTION ADMINISTRATION SET (February 22, 1985)
  • K850066 — OMNIMED NASAL OXYGEN CANNULA (January 24, 1985)
  • K831147 — OMNIPROBE ELECTRICAL NERVE STIMULATOR (July 18, 1983)
  • K821523 — OMNI TENS (June 16, 1982)

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