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510(k) K823214

DOSIMETRIC RELEASE PROGRAM - ADMIN. SET by Cutter Laboratories, Inc. — Product Code FPA

K823214 is an FDA 510(k) premarket notification submitted by Cutter Laboratories, Inc. for the device "DOSIMETRIC RELEASE PROGRAM - ADMIN. SET". The FDA issued a decision of Substantially Equivalent on January 12, 1983. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Cutter Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 12, 1983
Date Received
October 28, 1982
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 Cutter Laboratories, Inc.

  • K861315 — HYPERBARIC PENETRATION EXTENSION SET (May 21, 1986)
  • K854106 — BAYSILEX (March 17, 1986)
  • K842324 — PERFOURM (November 9, 1984)
  • K834106 — INTRAVENOUS INFUSION CONTROLLER (May 30, 1984)
  • K832237 — ORTHOPEDIC CASTING TAPE MAXCAST (August 16, 1983)
  • K821326 — CUTTER BOND POLYCARBOXYLATE CEMENT (May 28, 1982)
  • K813532 — CUTTERBOND ZINC PHOSPHATE CEMENT (March 2, 1982)
  • K802105 — C-BLADE (September 16, 1980)
  • K802104 — C-SPLINT (September 16, 1980)
  • K801652 — TOTAL PARENTERAL NUTRITION SET BAG (August 27, 1980)

Other clearances for product code FPA

  • 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)
  • K250616 — Clave™ Neutral-Displacement Needlefree Connectors (June 5, 2025)

FDA data resources