Cleared Traditional

PULSION PULSIOCATH, PULSION PCCO MONITORING KIT, PULSION IN-LINE INJECTATE SENSOR (K991886) - FDA 510(k) Clearance

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

K991886 · Pulsion Medical Systems, Inc. · Cardiovascular device
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May 2000
Decision
344d
Days
Class 2
Risk

K991886 is an FDA 510(k) clearance for the PULSION PULSIOCATH, PULSION PCCO MONITORING KIT, PULSION IN-LINE INJECTATE SE.... Classified as Probe, Thermodilution (product code KRB), Class II - Special Controls.

Submitted by Pulsion Medical Systems, Inc. (Wilmington, US). The FDA issued a Cleared decision on May 11, 2000 after a review of 344 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1915 - 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K991886 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 1999
Decision Date May 11, 2000
Days to Decision 344 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
219d slower than avg
Panel avg: 125d · This submission: 344d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KRB Probe, Thermodilution
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1915
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.