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510(k) K942625

1.2 MICRON AIR ELIMINATING FILTER by The Medi-Dose Group — Product Code FPB

K942625 is an FDA 510(k) premarket notification submitted by The Medi-Dose Group for the device "1.2 MICRON AIR ELIMINATING FILTER". The FDA issued a decision of Substantially Equivalent on October 7, 1994. The device falls under product code FPB (Filter, Infusion Line), a Class II device regulated under 21 CFR 880.5440. The Medi-Dose Group has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 7, 1994
Date Received
June 2, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Filter, Infusion Line
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

Other clearances by The Medi-Dose Group

  • K952242 — TRANSFEER SPIKE II (September 15, 1995)
  • K900651 — TS-1800 MEDICATION TRANSFER SPIKE (May 7, 1990)
  • K895291 — IV DISPESNSING SPIKE (December 27, 1989)
  • K895290 — CHEMO-SPIKE RECONSTITUTION DEVICE (December 27, 1989)
  • K896291 — INJECTION PORT II --- FOR INTERMITTENT INJECTION (December 1, 1989)
  • K895419 — DISPOSABLE DISC FILTER (November 24, 1989)
  • K892429 — INJECTION PORT FOR---INTERMITTENT INJECTION (July 25, 1989)
  • K892430 — DISPOSABLE DISC FILTER (July 14, 1989)
  • K892428 — COMBI-CAP (July 14, 1989)

Other clearances for product code FPB

  • K233277 — Filter Needle for Single Use (May 10, 2024)
  • K143583 — Cathivex ¿GV filter units (August 11, 2015)
  • K113227 — NON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON FILTER (December 8, 2011)
  • K021293 — ARTERIA BLOOD FILTER (August 22, 2002)
  • K993379 — PALL SUPOR AEF FILTER (December 16, 1999)
  • K974661 — 0.2 U BACTERIAL FILTER (February 11, 1998)
  • K964283 — AUTOPRIME (January 22, 1997)
  • K954331 — PALL LEA FILTER (LIPID EMULSION FILTER) (I.V. FILTER) (January 9, 1997)
  • K933523 — I.V. FILTER SET (May 19, 1995)
  • K941628 — 40 MICRON BLOOD TRANSFUSION FILTER (February 16, 1995)

FDA data resources