Cleared Traditional

GAMBRO DQM 200 (K990039) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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.

View all Gambro Healthcare devices

Submission Details

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.

Device Classification

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.