Cleared Traditional

K853405 - ELECTROLYTE ANALYZER SERA-252

K853405 is the FDA 510(k) clearance for ELECTROLYTE ANALYZER SERA-252 by Horiba Instruments, Inc.. It is a Class 2 Chemistry device (product code CHL) cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K853405 · Horiba Instruments, Inc. · Chemistry device
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Dec 1985
Decision
114d
Days
Class 2
Risk

K853405 is an FDA 510(k) clearance for the ELECTROLYTE ANALYZER SERA-252. Classified as Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph (product code CHL), Class II - Special Controls.

Submitted by Horiba Instruments, Inc. (Irvine, US). The FDA issued a Cleared decision on December 4, 1985 after a review of 114 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1120 - 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 Horiba Instruments, Inc. devices

Submission Details

510(k) Number K853405 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1985
Decision Date December 04, 1985
Days to Decision 114 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d slower than avg
Panel avg: 88d · This submission: 114d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CHL Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1120
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 - CHL Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph

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