Cleared Traditional

K812800 - FLOW-DIRECTED THERMODILUTION CATHETER

K812800 is the FDA 510(k) clearance for FLOW-DIRECTED THERMODILUTION CATHETER by Sorensen Research. It is a Class 2 Cardiovascular device (product code KRB) cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K812800 · Sorensen Research · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1981
Decision
14d
Days
Class 2
Risk

K812800 is an FDA 510(k) clearance for the FLOW-DIRECTED THERMODILUTION CATHETER. Classified as Probe, Thermodilution (product code KRB), Class II - Special Controls.

Submitted by Sorensen Research (Walker, US). The FDA issued a Cleared decision on October 20, 1981 after a review of 14 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 Sorensen Research devices

Submission Details

510(k) Number K812800 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 1981
Decision Date October 20, 1981
Days to Decision 14 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
111d faster than avg
Panel avg: 125d · This submission: 14d
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 10
Devices cleared under the same product code (KRB) and FDA review panel - the closest regulatory comparables to K812800.
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
SWAN-GANZ HEPARIN COATED, ETC. CATHETER
K811411 · American Edwards Laboratories · Jun 1981
EDSLAB CLOSED INJECTATE DELIVERY SYSTEM
K811399 · American Edwards Laboratories · Jun 1981
USCI SAFE-T-CLOTH THERMODILUTION CAT.
K791873 · C.R. Bard, Inc. · Nov 1979