Cleared Traditional

K821057 - FLOW DIRECTED THERMAL-DILUTION INFUSION

K821057 is the FDA 510(k) clearance for FLOW DIRECTED THERMAL-DILUTION INFUSION by Oximetrix, Inc.. It is a Class 2 Cardiovascular device (product code DYG) cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K821057 · Oximetrix, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1982
Decision
32d
Days
Class 2
Risk

K821057 is an FDA 510(k) clearance for the FLOW DIRECTED THERMAL-DILUTION INFUSION. Classified as Catheter, Flow Directed (product code DYG), Class II - Special Controls.

Submitted by Oximetrix, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 18, 1982 after a review of 32 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 Oximetrix, Inc. devices

Submission Details

510(k) Number K821057 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 1982
Decision Date May 18, 1982
Days to Decision 32 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 125d · This submission: 32d
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 41
Devices cleared under the same product code (DYG) and FDA review panel - the closest regulatory comparables to K821057.
SWAN-GANZ BIPOLAR PACING CATHETER
K822723 · American Edwards Laboratories · Oct 1982
SWAN-GANZ FLOW-DIRECTED THERMODIL. CATH
K822350 · American Edwards Laboratories · Aug 1982
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
FLOW-DIRECTED THERMODILUTION CATHETER
K812324 · Sorensen Research · Sep 1981