Cleared Traditional

K864818 - ACKRAD TDI SET

K864818 is an FDA 510(k) clearance for ACKRAD TDI SET, manufactured by Ackrad Laboratories. The device is a Class 2 Cardiovascular device with product code KRB cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K864818 · Ackrad Laboratories · Cardiovascular device
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Apr 1987
Decision
121d
Days
Class 2
Risk

K864818 is an FDA 510(k) clearance for the ACKRAD TDI SET. Classified as Probe, Thermodilution (product code KRB), Class II - Special Controls.

Submitted by Ackrad Laboratories (Cranford, US). The FDA issued a Cleared decision on April 9, 1987 after a review of 121 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 Ackrad Laboratories devices

FDA 510(k) Submission Details - K864818

510(k) Number K864818 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1986
Decision Date April 09, 1987
Days to Decision 121 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
4d faster than avg
Panel avg: 125d · This submission: 121d
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 K864818.
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
NUMED BALLOON THERMODILUTION CATHETER
K881893 · NuMED, Inc. · Sep 1988
HEPARIN COATED THERMODILUTION CATHETERS
K840824 · Gould, Inc. · May 1984
THERMODILUTION CATHETER
K840992 · Gould, Inc. · May 1984
FLOW-DIRECTED THERMODILUTION CATHETER
K812800 · Sorensen Research · Oct 1981