Cleared Traditional

LOW VOLUME BIFURCATED IV EXTENSION SET (K901088) - FDA 510(k) Clearance

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

K901088 · Marquette Medical, Inc. · General Hospital
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Oct 1990
Decision
211d
Days
Class 2
Risk

K901088 is an FDA 510(k) clearance for the LOW VOLUME BIFURCATED IV EXTENSION SET. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Marquette Medical, Inc. (Crofton, US). The FDA issued a Cleared decision on October 4, 1990 after a review of 211 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 Marquette Medical, Inc. devices

Submission Details

510(k) Number K901088 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 1990
Decision Date October 04, 1990
Days to Decision 211 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
82d slower than avg
Panel avg: 129d · This submission: 211d
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 208
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K901088.
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K893646 · Baxter Healthcare Corp · Dec 1989