Cleared Traditional

K810730 - MODEL SP5107 THERMODILUTION CATHETER

K810730 is an FDA 510(k) clearance for MODEL SP5107 THERMODILUTION CATHETER, manufactured by Gould, Inc.. The device is a Class 2 Cardiovascular device with product code KRB cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K810730 · Gould, Inc. · Cardiovascular device
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Mar 1981
Decision
10d
Days
Class 2
Risk

K810730 is an FDA 510(k) clearance for the MODEL SP5107 THERMODILUTION CATHETER. Classified as Probe, Thermodilution (product code KRB), Class II - Special Controls.

Submitted by Gould, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 27, 1981 after a review of 10 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 Gould, Inc. devices

FDA 510(k) Submission Details - K810730

510(k) Number K810730 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 1981
Decision Date March 27, 1981
Days to Decision 10 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
115d faster than avg
Panel avg: 125d · This submission: 10d
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 18
Devices cleared under the same product code (KRB) and FDA review panel - the closest regulatory comparables to K810730.
SWAN-GANZ HEPARIN COATED, ETC. CATHETER
K811411 · American Edwards Laboratories · Jun 1981
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
USCI SAFE-T-CLOTH THERMODILUTION CAT.
K791873 · C.R. Bard, Inc. · Nov 1979
CATHETER, THERMAL DILUTION, ANIMAL & PED
K760064 · Instrumentation Laboratory CO · Jul 1976