Cleared Special

K023049 - SYNCHRON LX I 725 CLINICAL SYSTEM

K023049 is an FDA 510(k) clearance for SYNCHRON LX I 725 CLINICAL SYSTEM, manufactured by Beckman Coulter, Inc.. The device is a Class 2 Chemistry device with product code JGS cleared through the Special 510(k) pathway after a 22-day FDA review.

K023049 · Beckman Coulter, Inc. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2002
Decision
22d
Days
Class 2
Risk

K023049 is an FDA 510(k) clearance for the SYNCHRON LX I 725 CLINICAL SYSTEM. Classified as Electrode, Ion Specific, Sodium (product code JGS), Class II - Special Controls.

Submitted by Beckman Coulter, Inc. (Brea, US). The FDA issued a Cleared decision on October 4, 2002 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1665 - the FDA in vitro diagnostics and chemistry 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K023049

510(k) Number K023049 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 2002
Decision Date October 04, 2002
Days to Decision 22 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 89d · This submission: 22d
Pathway characteristics
Modification to existing cleared device.

JGS Device Classification - Class 2, Special Controls

Product Code JGS Electrode, Ion Specific, Sodium
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1665
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 Chemistry devices follow this clearance model.

Regulatory Peers - JGS Electrode, Ion Specific, Sodium

All 159
Devices cleared under the same product code (JGS) and FDA review panel - the closest regulatory comparables to K023049.
ISE DILUENT, 1N KCL, INTERNAL REFERENCE AND ISE STANDARDS LOW AND HIGH
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GENCHEM ISE ELECTROLYTE REFERENCE
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PHOENIX ISE REAGENTS FOR BECKMAN CX SYSTEMS
K020364 · Phoenix Diagnostics, Inc. · Jun 2002
MODIFICATION TO SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM
K011213 · Beckman Coulter, Inc. · May 2001
EASYELECTROLYTE NA/K/LI ANALYZER & RAPIDLYTE NA/K/LI ANALYZER
K002407 · Medica Corp. · Feb 2001
K023049 · SYNCHRON LX I 725 CLINICAL SYSTEM
Download PDF FDA Summary Beckman Coulter, Inc.