Cleared Traditional

K122162 - AGGREGUIDE (FDA 510(k) Clearance)

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

K122162 · Aggredyne, Inc. · Hematology device
Dec 2013
Decision
518d
Days
Class 2
Risk

K122162 is an FDA 510(k) clearance for the AGGREGUIDE. Classified as System, Automated Platelet Aggregation (product code JOZ), Class II - Special Controls.

Submitted by Aggredyne, Inc. (Houston, US). The FDA issued a Cleared decision on December 20, 2013 after a review of 518 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5700 - the FDA hematology 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Hematology submissions.

Submission Details

510(k) Number K122162 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 2012
Decision Date December 20, 2013
Days to Decision 518 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
313d slower than avg
Panel avg: 205d · This submission: 518d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JOZ System, Automated Platelet Aggregation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5700
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 Hematology devices follow this clearance model.