Cleared Traditional

K841280 - SOLOPAK BRAND FILTER NEEDLE W/5 MICRO

K841280 is the FDA 510(k) clearance for SOLOPAK BRAND FILTER NEEDLE W/5 MICRO by Smith & Nephew, Mpl Division. It is a Class 2 General Hospital device (product code FPB) cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K841280 · Smith & Nephew, Mpl Division · General Hospital
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May 1984
Decision
54d
Days
Class 2
Risk

K841280 is an FDA 510(k) clearance for the SOLOPAK BRAND FILTER NEEDLE W/5 MICRO. Classified as Filter, Infusion Line (product code FPB), Class II - Special Controls.

Submitted by Smith & Nephew, Mpl Division (Mchenry, US). The FDA issued a Cleared decision on May 21, 1984 after a review of 54 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Smith & Nephew, Mpl Division devices

Submission Details

510(k) Number K841280 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 1984
Decision Date May 21, 1984
Days to Decision 54 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 129d · This submission: 54d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FPB Filter, Infusion Line
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FPB Filter, Infusion Line

All 28
Devices cleared under the same product code (FPB) and FDA review panel - the closest regulatory comparables to K841280.
CONTINU-FLO SOLUTION ADMIN. SET W/IN-LINE FILTER
K865029 · Travenol Laboratories, S.A. · Apr 1987
AUTO SYRINGE MICRO VOL EXT SET W/AIR VENT FILTER
K860746 · Travenol Laboratories, S.A. · Apr 1986
PREVENT 0.2 MICRON IV FILTER W/VENT & EXTENSION SE
K855065 · Cobe Laboratories, Inc. · Feb 1986
IVEX-INT
K833684 · Abbott Laboratories · Dec 1983
CONTINU-FLO SOLUTION ADMINISTRATION
K831668 · Travenol Laboratories, S.A. · Aug 1983
IVEX-HP PEDIATRIC EXTENSION SET-SL
K821013 · Abbott Laboratories · Jul 1982