Cleared Traditional

K823435 - MON-A-THERM MYOCARDIAL TEMP. SENSOR

K823435 is the FDA 510(k) clearance for MON-A-THERM MYOCARDIAL TEMP. SENSOR by Burditt & Calkins-Siemens-Elema. It is a Class 2 Cardiovascular device (product code KRB) cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K823435 · Burditt & Calkins-Siemens-Elema · Cardiovascular device
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Dec 1982
Decision
44d
Days
Class 2
Risk

K823435 is an FDA 510(k) clearance for the MON-A-THERM MYOCARDIAL TEMP. SENSOR. Classified as Probe, Thermodilution (product code KRB), Class II - Special Controls.

Submitted by Burditt & Calkins-Siemens-Elema (Walker, US). The FDA issued a Cleared decision on December 30, 1982 after a review of 44 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 Burditt & Calkins-Siemens-Elema devices

Submission Details

510(k) Number K823435 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 1982
Decision Date December 30, 1982
Days to Decision 44 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 125d · This submission: 44d
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 12
Devices cleared under the same product code (KRB) and FDA review panel - the closest regulatory comparables to K823435.
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K884318 · Abbott Laboratories · Dec 1988
FLOW-DIRECTED THERMODILUTION CATHETER
K812800 · Sorensen Research · Oct 1981
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K811411 · American Edwards Laboratories · Jun 1981
EDSLAB CLOSED INJECTATE DELIVERY SYSTEM
K811399 · American Edwards Laboratories · Jun 1981