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510(k) K904663

AUTO SASH (TM) by Block Medical, Inc. — Product Code FPA

K904663 is an FDA 510(k) premarket notification submitted by Block Medical, Inc. for the device "AUTO SASH (TM)". The FDA issued a decision of Substantially Equivalent on November 23, 1992. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Block Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 23, 1992
Date Received
October 12, 1990
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 Block Medical, Inc.

  • K944692 — C-SERIES HOMEPUMP (May 2, 1995)
  • K940117 — MID-500 (June 10, 1994)
  • K934551 — VERIFUSE AMBULATORY PUMP (March 17, 1994)
  • K935236 — FLOW CONTROLLING EXTENSION SET (February 24, 1994)
  • K932740 — HOMEPUMP NSF (October 6, 1993)
  • K914924 — CHEMO PRIMING PIN(TM) (March 6, 1992)
  • K914854 — THUMPER (January 24, 1992)
  • K914855 — MULTIPLE DOSE CONTROLLER (January 24, 1992)
  • K910695 — AUTO SASH (TM) (March 21, 1991)
  • K902891 — VERIFUSE AMBULATORY PUMP (November 21, 1990)

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