Cleared Traditional

K812324 - FLOW-DIRECTED THERMODILUTION CATHETER

K812324 is the FDA 510(k) clearance for FLOW-DIRECTED THERMODILUTION CATHETER by Sorensen Research. It is a Class 2 Cardiovascular device (product code DYG) cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K812324 · Sorensen Research · Cardiovascular device
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Sep 1981
Decision
39d
Days
Class 2
Risk

K812324 is an FDA 510(k) clearance for the FLOW-DIRECTED THERMODILUTION CATHETER. Classified as Catheter, Flow Directed (product code DYG), Class II - Special Controls.

Submitted by Sorensen Research (Mchenry, US). The FDA issued a Cleared decision on September 25, 1981 after a review of 39 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1240 - 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 K812324 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 1981
Decision Date September 25, 1981
Days to Decision 39 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
86d faster than avg
Panel avg: 125d · This submission: 39d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DYG Catheter, Flow Directed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1240
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 - DYG Catheter, Flow Directed

All 40
Devices cleared under the same product code (DYG) and FDA review panel - the closest regulatory comparables to K812324.
MEDTRONIC S3 TM SYSTEM
K821004 · Medtronic Vascular · May 1982
IL 7F FLOW DIRECTOR THERMAL DILU. CATH
K820702 · Instrumentation Laboratory CO · Apr 1982
SWAN-GANZ VIP-CATHETER
K820222 · American Edwards Laboratories · Feb 1982
SWAN-GANZ & EDSLAB HEPARIN COATED CATH.
K812563 · American Edwards Laboratories · Sep 1981
SWAN-GANZ FLOW-DIRECTED THERMODILUTION
K810352 · American Edwards Laboratories · Mar 1981
SWAN-GANZ VIP THERMODILUTION CATHETER
K810124 · American Edwards Laboratories · Feb 1981