Cleared Traditional

K002738 - BAYER RAPIDPOINT 400 SYSTEM

K002738 is an FDA 510(k) clearance for BAYER RAPIDPOINT 400 SYSTEM, manufactured by Bayer Corp.. The device is a Class 2 Chemistry device with product code CHL cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K002738 · Bayer Corp. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2000
Decision
109d
Days
Class 2
Risk

K002738 is an FDA 510(k) clearance for the BAYER RAPIDPOINT 400 SYSTEM. Classified as Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph (product code CHL), Class II - Special Controls.

Submitted by Bayer Corp. (Medfield, US). The FDA issued a Cleared decision on December 19, 2000 after a review of 109 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.

FDA 510(k) Submission Details - K002738

510(k) Number K002738 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 2000
Decision Date December 19, 2000
Days to Decision 109 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
20d slower than avg
Panel avg: 89d · This submission: 109d
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 187
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K002738 · BAYER RAPIDPOINT 400 SYSTEM
Download PDF FDA Summary Bayer Corp.