Cleared Traditional

K881893 - NUMED BALLOON THERMODILUTION CATHETER

K881893 is an FDA 510(k) clearance for NUMED BALLOON THERMODILUTION CATHETER, manufactured by NuMED, Inc.. The device is a Class 2 Cardiovascular device with product code KRB cleared through the Traditional 510(k) pathway after a 124-day FDA review.

K881893 · NuMED, Inc. · Cardiovascular device
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Sep 1988
Decision
124d
Days
Class 2
Risk

K881893 is an FDA 510(k) clearance for the NUMED BALLOON THERMODILUTION CATHETER. Classified as Probe, Thermodilution (product code KRB), Class II - Special Controls.

Submitted by NuMED, Inc. (Hopkinton, US). The FDA issued a Cleared decision on September 6, 1988 after a review of 124 days - within the typical 510(k) review window.

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 NuMED, Inc. devices

FDA 510(k) Submission Details - K881893

510(k) Number K881893 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 1988
Decision Date September 06, 1988
Days to Decision 124 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
1d faster than avg
Panel avg: 125d · This submission: 124d
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 24
Devices cleared under the same product code (KRB) and FDA review panel - the closest regulatory comparables to K881893.
CRITIKIT PLUS IN LINE ROOM/ICE TEMPERATURE INJECTATE KIT
K936182 · Ohmeda Medical · Mar 1994
INTERFLO MEDICAL MODEL F-1 THERMODILUTION CATHETER
K900710 · Intec Medical, Inc. · Oct 1990
THERMOSET(TM) CLOSED LOOP DELIVERY SYSTEM
K884318 · Abbott Laboratories · Dec 1988
MODIFIED MYOCARDIAL TEMPERATURE SENSOR
K874522 · Mon-A-Therm, Inc. · Jan 1988
ACKRAD TDI SET
K864818 · Ackrad Laboratories · Apr 1987
FLOW-DIRECTED PEDIATRIC THERMODIL- CATH
K843410 · Andover Medical, Inc. · Nov 1984