Cleared Traditional

AIM-V (R) MEDIUM, MODEL 087-0112 (K022086) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K022086 · Invitrogen Corporation · Gastroenterology & Urology device
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Dec 2002
Decision
179d
Days
Class 2
Risk

K022086 is an FDA 510(k) clearance for the AIM-V (R) MEDIUM, MODEL 087-0112. Classified as Media, Culture, Ex Vivo, Tissue And Cell (product code NDS), Class II - Special Controls.

Submitted by Invitrogen Corporation (Grand Island, US). The FDA issued a Cleared decision on December 23, 2002 after a review of 179 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5885 - the FDA gastroenterology and urology 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 Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Invitrogen Corporation devices

Submission Details

510(k) Number K022086 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 2002
Decision Date December 23, 2002
Days to Decision 179 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d slower than avg
Panel avg: 130d · This submission: 179d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NDS Media, Culture, Ex Vivo, Tissue And Cell
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5885
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 Gastroenterology & Urology devices follow this clearance model.