Cleared Traditional

K121823 - CLINICAL CHLORIDE ANALYZER, CHLORIDE TEST SYSTEM, SWEAT CHLORIDE ANALYZER, CHLORIDOMETER, CHLORIDE COULOMETRIC

K121823 is an FDA 510(k) clearance for CLINICAL CHLORIDE ANALYZER, manufactured by Wescor, Inc.. The device is a Class 2 Chemistry device with product code JFS cleared through the Traditional 510(k) pathway after a 279-day FDA review.

K121823 · Wescor, Inc. · Chemistry device
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Optimized for regulatory review, auditing and printing
Mar 2013
Decision
279d
Days
Class 2
Risk

K121823 is an FDA 510(k) clearance for the CLINICAL CHLORIDE ANALYZER, CHLORIDE TEST SYSTEM, SWEAT CHLORIDE ANALYZER, CH.... Classified as Coulometric, Chloride (product code JFS), Class II - Special Controls.

Submitted by Wescor, Inc. (Logan, US). The FDA issued a Cleared decision on March 27, 2013 after a review of 279 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1170 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Wescor, Inc. devices

FDA 510(k) Submission Details - K121823

510(k) Number K121823 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 2012
Decision Date March 27, 2013
Days to Decision 279 days
Submission Type Traditional
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
191d slower than avg
Panel avg: 88d · This submission: 279d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JFS Device Classification - Class 2, Special Controls

Product Code JFS Coulometric, Chloride
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1170
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 - JFS Coulometric, Chloride

All 13
Devices cleared under the same product code (JFS) and FDA review panel - the closest regulatory comparables to K121823.
REDI-CHECK PHOTMETER Q.A.
K923598 · Awareness Technology, Inc. · Oct 1992
REAGENTS CORNING CHLORIDE METER FOR
K830217 · Fisher Scientific Co., LLC · Feb 1983
LIQUIZYME CHLORIDE REAGENT
K820411 · American Research Products Co. · Mar 1982
SILVER ANODE
K810550 · Nobel Scientific Industries, Inc. · Apr 1981
CORNING 925 CHLORIDE METER
K810615 · Corning Medical & Scientific · Mar 1981
BAKER DIAG. ULTRARATE CHLORIDE KIT
K802080 · J.T. Baker Chemical Co. · Oct 1980