Cleared Traditional

K831404 - BLOOD MONITOR BMM 10-4

K831404 is an FDA 510(k) clearance for BLOOD MONITOR BMM 10-4, manufactured by Gambro, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code LLB cleared through the Traditional 510(k) pathway after a 359-day FDA review.

K831404 · Gambro, Inc. · Gastroenterology & Urology device
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Apr 1984
Decision
359d
Days
Class 2
Risk

K831404 is an FDA 510(k) clearance for the BLOOD MONITOR BMM 10-4. Classified as System, Blood, Extracorporeal And Accessories (product code LLB), Class II - Special Controls.

Submitted by Gambro, Inc. (Walker, US). The FDA issued a Cleared decision on April 25, 1984 after a review of 359 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5820 - the FDA gastroenterology and urology device 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 Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Gambro, Inc. devices

FDA 510(k) Submission Details - K831404

510(k) Number K831404 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 1983
Decision Date April 25, 1984
Days to Decision 359 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
229d slower than avg
Panel avg: 130d · This submission: 359d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LLB Device Classification - Class 2, Special Controls

Product Code LLB System, Blood, Extracorporeal And Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5820
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 Gastroenterology & Urology devices follow this clearance model.