Cleared Traditional

K881893 - NUMED BALLOON THERMODILUTION CATHETER

K881893 is the FDA 510(k) clearance for NUMED BALLOON THERMODILUTION CATHETER by NuMED, Inc.. It is a Class 2 Cardiovascular device (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

Submission Details

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.

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 14
Devices cleared under the same product code (KRB) and FDA review panel - the closest regulatory comparables to K881893.
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
ACKRAD TDI SET
K864818 · Ackrad Laboratories · Apr 1987
FLOW-DIRECTED THERMODILUTION CATHETER
K812800 · Sorensen Research · Oct 1981
SWAN-GANZ HEPARIN COATED, ETC. CATHETER
K811411 · American Edwards Laboratories · Jun 1981