Cleared Traditional

K892941 - CCO SYSTEM MODEL SP1467

K892941 is the FDA 510(k) clearance for CCO SYSTEM MODEL SP1467 by Spectramed, Inc.. It is a Class 2 Cardiovascular device (product code KRB) cleared through the Traditional 510(k) pathway after a 199-day FDA review.

K892941 · Spectramed, Inc. · Cardiovascular device
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Nov 1989
Decision
199d
Days
Class 2
Risk

K892941 is an FDA 510(k) clearance for the CCO SYSTEM MODEL SP1467,SP5567,SP6267. Classified as Probe, Thermodilution (product code KRB), Class II - Special Controls.

Submitted by Spectramed, Inc. (Oxnard, US). The FDA issued a Cleared decision on November 6, 1989 after a review of 199 days - an extended review 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: 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 Spectramed, Inc. devices

Submission Details

510(k) Number K892941 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 1989
Decision Date November 06, 1989
Days to Decision 199 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d slower than avg
Panel avg: 125d · This submission: 199d
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 15
Devices cleared under the same product code (KRB) and FDA review panel - the closest regulatory comparables to K892941.
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
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