Cleared Traditional

K791873 - USCI SAFE-T-CLOTH THERMODILUTION CAT.

K791873 is the FDA 510(k) clearance for USCI SAFE-T-CLOTH THERMODILUTION CAT. by C.R. Bard, Inc.. It is a Class 2 Cardiovascular device (product code KRB) cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K791873 · C.R. Bard, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1979
Decision
53d
Days
Class 2
Risk

K791873 is an FDA 510(k) clearance for the USCI SAFE-T-CLOTH THERMODILUTION CAT.. Classified as Probe, Thermodilution (product code KRB), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 13, 1979 after a review of 53 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 C.R. Bard, Inc. devices

Submission Details

510(k) Number K791873 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 1979
Decision Date November 13, 1979
Days to Decision 53 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
72d faster than avg
Panel avg: 125d · This submission: 53d
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 K791873.
EDSLAB CLOSED INJECTATE DELIVERY SYSTEM
K811399 · American Edwards Laboratories · Jun 1981
THERMODILUTION KIT
K811480 · American Pharmaseal Div. Ahsc · Jun 1981
BENTLEY THEROMODILUTION CATHETER #BTD-7F
K802133 · Bentley Laboratories, Inc. · Sep 1980
CATHETER, THERMAL DILUTION, ANIMAL & PED
K760064 · Instrumentation Laboratory CO · Jul 1976
CATHETER, THERMAL DILUTION, PEDIATRIC
K760065 · Instrumentation Laboratory CO · Jul 1976
CATHETER, THERMAL DILUTION, OPEN CHEST
K760067 · Instrumentation Laboratory CO · Jul 1976