Cleared Traditional

K182110 - CDI Blood Parameter Monitoring System 550 (FDA 510(k) Clearance)

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

K182110 · Terumo Cardiovascular Systems Corporation · Cardiovascular device
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Nov 2018
Decision
88d
Days
Class 2
Risk

K182110 is an FDA 510(k) clearance for the CDI Blood Parameter Monitoring System 550. Classified as Monitor, Blood-gas, On-line, Cardiopulmonary Bypass (product code DRY), Class II - Special Controls.

Submitted by Terumo Cardiovascular Systems Corporation (Ann Arbor, US). The FDA issued a Cleared decision on November 2, 2018 after a review of 88 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Terumo Cardiovascular Systems Corporation devices

Submission Details

510(k) Number K182110 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2018
Decision Date November 02, 2018
Days to Decision 88 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 125d · This submission: 88d
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.