Cleared Traditional

K990039 - GAMBRO DQM 200

K990039 is an FDA 510(k) clearance for GAMBRO DQM 200, manufactured by Gambro Healthcare. The device is a Class 2 Chemistry device with product code LFP cleared through the Traditional 510(k) pathway after a 386-day FDA review.

K990039 · Gambro Healthcare · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2000
Decision
386d
Days
Class 2
Risk

K990039 is an FDA 510(k) clearance for the GAMBRO DQM 200. Classified as Conductivity Rate, Urea Nitrogen (product code LFP), Class II - Special Controls.

Submitted by Gambro Healthcare (Lakewood, US). The FDA issued a Cleared decision on January 27, 2000 after a review of 386 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1770 - 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

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FDA 510(k) Submission Details - K990039

510(k) Number K990039 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 1999
Decision Date January 27, 2000
Days to Decision 386 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
298d slower than avg
Panel avg: 88d · This submission: 386d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LFP Device Classification - Class 2, Special Controls

Product Code LFP Conductivity Rate, Urea Nitrogen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1770
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.