Cleared Traditional

K090147 - BLOOD MONITORING UNIT

K090147 is the FDA 510(k) clearance for BLOOD MONITORING UNIT by Maquet Cardiopulmonary, AG. It is a Class 2 Cardiovascular device (product code DRY) cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K090147 · Maquet Cardiopulmonary, AG · Cardiovascular device
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Apr 2009
Decision
91d
Days
Class 2
Risk

K090147 is an FDA 510(k) clearance for the BLOOD MONITORING UNIT, MODEL BMU 40. Classified as Monitor, Blood-gas, On-line, Cardiopulmonary Bypass (product code DRY), Class II - Special Controls.

Submitted by Maquet Cardiopulmonary, AG (Hirrlingen, DE). The FDA issued a Cleared decision on April 22, 2009 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4330 - the FDA cardiovascular device oversight 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 Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Maquet Cardiopulmonary, AG devices

Submission Details

510(k) Number K090147 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 2009
Decision Date April 22, 2009
Days to Decision 91 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 125d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DRY Monitor, Blood-gas, On-line, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4330
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DRY Monitor, Blood-gas, On-line, Cardiopulmonary Bypass

All 20
Devices cleared under the same product code (DRY) and FDA review panel - the closest regulatory comparables to K090147.
TRI-OPTIC MEASUREMENT CELL
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