Cleared Traditional

K954482 - SENDX 100 PH, BLOOD GAS & ELECTROLYTE ANALYSIS SYSTEM

K954482 is an FDA 510(k) clearance for SENDX 100 PH, manufactured by Cirrus Medical,Inc.. The device is a Class 2 Chemistry device with product code CHL cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K954482 · Cirrus Medical,Inc. · Chemistry device
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Dec 1995
Decision
68d
Days
Class 2
Risk

K954482 is an FDA 510(k) clearance for the SENDX 100 PH, BLOOD GAS & ELECTROLYTE ANALYSIS SYSTEM. Classified as Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph (product code CHL), Class II - Special Controls.

Submitted by Cirrus Medical,Inc. (La Jolla, US). The FDA issued a Cleared decision on December 4, 1995 after a review of 68 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Cirrus Medical,Inc. devices

FDA 510(k) Submission Details - K954482

510(k) Number K954482 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 1995
Decision Date December 04, 1995
Days to Decision 68 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 88d · This submission: 68d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CHL Device Classification - Class 2, Special Controls

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

All 162
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