Cleared Traditional

K936182 - CRITIKIT PLUS IN LINE ROOM/ICE TEMPERAT...

K936182 is the FDA 510(k) clearance for CRITIKIT PLUS IN LINE ROOM/ICE TEMPERAT... by Ohmeda Medical. It is a Class 2 Cardiovascular device (product code KRB) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K936182 · Ohmeda Medical · Cardiovascular device
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Mar 1994
Decision
88d
Days
Class 2
Risk

K936182 is an FDA 510(k) clearance for the CRITIKIT PLUS IN LINE ROOM/ICE TEMPERATURE INJECTATE KIT. Classified as Probe, Thermodilution (product code KRB), Class II - Special Controls.

Submitted by Ohmeda Medical (Oxnard, US). The FDA issued a Cleared decision on March 25, 1994 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1915 - 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: 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 Ohmeda Medical devices

Submission Details

510(k) Number K936182 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1993
Decision Date March 25, 1994
Days to Decision 88 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
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 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 14
Devices cleared under the same product code (KRB) and FDA review panel - the closest regulatory comparables to K936182.
PiCCO Catheter
K171620 · Pulsion Medical Systems SE · Feb 2018
VOLUMEVIEW SYSTEM, MODELS VLV520FT6R, VLV520FT8R, VLV520FT6R5
K100739 · Edwards Lifesciences, LLC · Dec 2010
THERMOSET(TM) CLOSED LOOP DELIVERY SYSTEM
K884318 · Abbott Laboratories · Dec 1988
NUMED BALLOON THERMODILUTION CATHETER
K881893 · NuMED, Inc. · Sep 1988
ACKRAD TDI SET
K864818 · Ackrad Laboratories · Apr 1987
FLOW-DIRECTED THERMODILUTION CATHETER
K812800 · Sorensen Research · Oct 1981