Cleared Traditional

K812800 - FLOW-DIRECTED THERMODILUTION CATHETER

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

K812800 · Sorensen Research · Cardiovascular device
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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

FDA 510(k) Submission Details - K812800

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.

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 23
Devices cleared under the same product code (KRB) and FDA review panel - the closest regulatory comparables to K812800.
HEPARIN COATED THERMODILUTION CATHETERS
K840824 · Gould, Inc. · May 1984
THERMODILUTION CATHETER
K840992 · Gould, Inc. · May 1984
MIKRO-TIP CATH. PRESSURE TRANSDUCER
K830909 · Millar Instruments, Inc. · Apr 1983
MODEL SP 5507 5-LUMEN THERMODILUTION CAT
K811537 · Gould, Inc. · Jun 1981
SWAN-GANZ HEPARIN COATED, ETC. CATHETER
K811411 · American Edwards Laboratories · Jun 1981
EDSLAB CLOSED INJECTATE DELIVERY SYSTEM
K811399 · American Edwards Laboratories · Jun 1981