Cleared Special

K161329 - Chrono-log Platelet Aggregometer, 4 channel (FDA 510(k) Clearance)

Also includes:
Chrono-log Platelet Aggregometer, 8 channel

Class II Hematology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K161329 · Chrono-Log Corp. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2016
Decision
204d
Days
Class 2
Risk

K161329 is an FDA 510(k) clearance for the Chrono-log Platelet Aggregometer, 4 channel. Classified as System, Automated Platelet Aggregation (product code JOZ), Class II - Special Controls.

Submitted by Chrono-Log Corp. (Havertown, US). The FDA issued a Cleared decision on December 2, 2016 after a review of 204 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5700 - the FDA hematology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Chrono-Log Corp. devices

Submission Details

510(k) Number K161329 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 2016
Decision Date December 02, 2016
Days to Decision 204 days
Submission Type Special
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
91d slower than avg
Panel avg: 113d · This submission: 204d
Pathway characteristics
Modification to existing cleared device.

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.