Cleared Traditional

K885031 - LOW ADSORPTION ADMINISTRATION SET

K885031 is the FDA 510(k) clearance for LOW ADSORPTION ADMINISTRATION SET by 3M Company. It is a Class 2 General Hospital device (product code FPA) cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K885031 · 3M Company · General Hospital
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May 1989
Decision
151d
Days
Class 2
Risk

K885031 is an FDA 510(k) clearance for the LOW ADSORPTION ADMINISTRATION SET. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by 3M Company (St. Paul, US). The FDA issued a Cleared decision on May 5, 1989 after a review of 151 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all 3M Company devices

Submission Details

510(k) Number K885031 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 1988
Decision Date May 05, 1989
Days to Decision 151 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
22d slower than avg
Panel avg: 129d · This submission: 151d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FPA Set, Administration, Intravascular
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 - FPA Set, Administration, Intravascular

All 462
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K885031.
SURFLO(R) WINGED INFUSION SET
K891063 · Terumo Medical Corp. · Jun 1989
TERUMO SURFLO(R) INJECTION PLUG
K891146 · Terumo Medical Corp. · Jun 1989
EXTENSION SET W/FLOW REGULATOR
K890489 · Baxter Healthcare Corp · Jun 1989
MONOPLACE HYPERBARIC EXTENSION SET (L 11055)
K884141 · Abbott Laboratories · Feb 1989
CRIS ADAPTER
K883986 · Y · Feb 1989
MODIFIED 7 INCH CONTINUOUS INFUSION SETS
K884102 · Quinton, Inc. · Jan 1989