Cleared Traditional

K991886 - PULSION PULSIOCATH, PULSION PCCO MONITORING KIT, PULSION IN-LINE INJECTATE SENSOR

K991886 is an FDA 510(k) clearance for PULSION PULSIOCATH, manufactured by Pulsion Medical Systems, Inc.. The device is a Class 2 Cardiovascular device with product code KRB cleared through the Traditional 510(k) pathway after a 344-day FDA review.

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.

View all Pulsion Medical Systems, Inc. devices

FDA 510(k) Submission Details - K991886

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.

KRB Device Classification - Class 2, Special Controls

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.

Regulatory Peers - KRB Probe, Thermodilution

All 24
Devices cleared under the same product code (KRB) and FDA review panel - the closest regulatory comparables to K991886.
PiCCO Catheter
K171620 · Pulsion Medical Systems SE · Feb 2018
VOLUMEVIEW SYSTEM, MODELS VLV520FT6R, VLV520FT8R, VLV520FT6R5
K100739 · Edwards Lifesciences, LLC · Dec 2010
CRITIKIT PLUS IN LINE ROOM/ICE TEMPERATURE INJECTATE KIT
K936182 · Ohmeda Medical · Mar 1994
INTERFLO MEDICAL MODEL F-1 THERMODILUTION CATHETER
K900710 · Intec Medical, Inc. · Oct 1990
THERMOSET(TM) CLOSED LOOP DELIVERY SYSTEM
K884318 · Abbott Laboratories · Dec 1988
NUMED BALLOON THERMODILUTION CATHETER
K881893 · NuMED, Inc. · Sep 1988