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510(k) K841280

SOLOPAK BRAND FILTER NEEDLE W/5 MICRO by Smith & Nephew, Mpl Division — Product Code FPB

K841280 is an FDA 510(k) premarket notification submitted by Smith & Nephew, Mpl Division for the device "SOLOPAK BRAND FILTER NEEDLE W/5 MICRO". The FDA issued a decision of Substantially Equivalent on May 21, 1984. The device falls under product code FPB (Filter, Infusion Line), a Class II device regulated under 21 CFR 880.5440. Smith & Nephew, Mpl Division has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 21, 1984
Date Received
March 28, 1984
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 Smith & Nephew, Mpl Division

  • K843314 — MPL HYPO BRAND BREECH LOAD ASPIR SYRINGE (September 27, 1984)
  • K840237 — MAX-I-PROBE PERIODONTAL ENDODONTIC PROB (April 5, 1984)
  • K833304 — HYPO BRAND DISPOS. DENTAL NEEDLES-PLAST (March 30, 1984)
  • K832126 — MICRO Z DISPOS. SPINAL ANESTH. NEEDLE (August 12, 1983)
  • K831765 — HERAPIN LOCK FLUSH SOLUTION USE KIT (July 12, 1983)
  • K830524 — HENKE JECT PRESSURE SYRINGE (March 24, 1983)
  • K830242 — MICRO 2 HYPODERMIC NEEDLES (February 15, 1983)
  • K761206 — INTEROSSEOUS NEEDLE (December 13, 1976)

Other clearances for product code FPB

  • K261403 — Lipipor NLF1A Infusion Filter, Lipipor NLF2A & NLF2NTA Infusion Filters, Lipipor (August 31, 2026)
  • 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)

FDA data resources