Cleared Traditional

K921391 - SOLUTION ADMINISTRATION SET (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K921391 · Douglas Medical Products Corp. · General Hospital
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Sep 1992
Decision
163d
Days
Class 2
Risk

K921391 is an FDA 510(k) clearance for the SOLUTION ADMINISTRATION SET. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Douglas Medical Products Corp. (Mundelein, US). The FDA issued a Cleared decision on September 2, 1992 after a review of 163 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 Douglas Medical Products Corp. devices

Submission Details

510(k) Number K921391 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 1992
Decision Date September 02, 1992
Days to Decision 163 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d slower than avg
Panel avg: 128d · This submission: 163d
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 1173
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