Cleared Traditional

K900710 - INTERFLO MEDICAL MODEL F-1 THERMODILUTI...

K900710 is the FDA 510(k) clearance for INTERFLO MEDICAL MODEL F-1 THERMODILUTI... by Intec Medical, Inc.. It is a Class 2 Cardiovascular device (product code KRB) cleared through the Traditional 510(k) pathway after a 247-day FDA review.

K900710 · Intec Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1990
Decision
247d
Days
Class 2
Risk

K900710 is an FDA 510(k) clearance for the INTERFLO MEDICAL MODEL F-1 THERMODILUTION CATHETER. Classified as Probe, Thermodilution (product code KRB), Class II - Special Controls.

Submitted by Intec Medical, Inc. (Plano, US). The FDA issued a Cleared decision on October 19, 1990 after a review of 247 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Intec Medical, Inc. devices

Submission Details

510(k) Number K900710 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 1990
Decision Date October 19, 1990
Days to Decision 247 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
122d slower than avg
Panel avg: 125d · This submission: 247d
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 11
Devices cleared under the same product code (KRB) and FDA review panel - the closest regulatory comparables to K900710.
PiCCO Catheter
K171620 · Pulsion Medical Systems SE · Feb 2018
VOLUMEVIEW SYSTEM, MODELS VLV520FT6R, VLV520FT8R, VLV520FT6R5
K100739 · Edwards Lifesciences, LLC · Dec 2010
CRITIKIT PLUS IN LINE ROOM/ICE TEMPERATURE INJECTATE KIT
K936182 · Ohmeda Medical · Mar 1994
THERMOSET(TM) CLOSED LOOP DELIVERY SYSTEM
K884318 · Abbott Laboratories · Dec 1988
FLOW-DIRECTED THERMODILUTION CATHETER
K812800 · Sorensen Research · Oct 1981
SWAN-GANZ HEPARIN COATED, ETC. CATHETER
K811411 · American Edwards Laboratories · Jun 1981