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510(k) K942532

2 MICRON AIR ELIMINATING FILTER by Medi-Dose, Inc. — Product Code FPB

K942532 is an FDA 510(k) premarket notification submitted by Medi-Dose, Inc. for the device "2 MICRON AIR ELIMINATING FILTER". The FDA issued a decision of Substantially Equivalent on Aug 17, 1994. The device falls under product code FPB (Filter, Infusion Line), a Class II device regulated under 21 CFR 880.5440. Medi-Dose, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Aug 17, 1994
Date Received
May 27, 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 Medi-Dose, Inc.

  • K974431 — CHEMO-SPIKE II RECONSTITUTION DEVICE (Jan 8, 1998)
  • K952518 — SAFE CAP NEEDLE RECAPPING/UNCAPPING DEVICE (Jul 28, 1995)
  • K936015 — DISPOSABLE DISC FILTER (Dec 12, 1994)

Other clearances for product code FPB

  • K261403 — Lipipor NLF1A Infusion Filter, Lipipor NLF2A & NLF2NTA Infusion Filters, Lipipor (Aug 31, 2026)
  • K233277 — Filter Needle for Single Use (May 10, 2024)
  • K143583 — Cathivex ¿GV filter units (Aug 11, 2015)
  • K113227 — NON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON FILTER (Dec 8, 2011)
  • K021293 — ARTERIA BLOOD FILTER (Aug 22, 2002)
  • K993379 — PALL SUPOR AEF FILTER (Dec 16, 1999)
  • K974661 — 0.2 U BACTERIAL FILTER (Feb 11, 1998)
  • K964283 — AUTOPRIME (Jan 22, 1997)
  • K954331 — PALL LEA FILTER (LIPID EMULSION FILTER) (I.V. FILTER) (Jan 9, 1997)
  • K933523 — I.V. FILTER SET (May 19, 1995)

FDA data resources