Cleared Special

K982014 - STOCKERT COMPACT SYSTEM

K982014 is an FDA 510(k) clearance for STOCKERT COMPACT SYSTEM, manufactured by Stoeckert Instrumente. The device is a Class 2 Cardiovascular device with product code DTQ cleared through the Special 510(k) pathway after a 88-day FDA review.

K982014 · Stoeckert Instrumente · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1998
Decision
88d
Days
Class 2
Risk

K982014 is an FDA 510(k) clearance for the STOCKERT COMPACT SYSTEM. Classified as Console, Heart-lung Machine, Cardiopulmonary Bypass (product code DTQ), Class II - Special Controls.

Submitted by Stoeckert Instrumente (North Attleboro, US). The FDA issued a Cleared decision on September 4, 1998 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4220 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Stoeckert Instrumente devices

FDA 510(k) Submission Details - K982014

510(k) Number K982014 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 1998
Decision Date September 04, 1998
Days to Decision 88 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 125d · This submission: 88d
Pathway characteristics
Modification to existing cleared device.

DTQ Device Classification - Class 2, Special Controls

Product Code DTQ Console, Heart-lung Machine, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4220
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 - DTQ Console, Heart-lung Machine, Cardiopulmonary Bypass

All 41
Devices cleared under the same product code (DTQ) and FDA review panel - the closest regulatory comparables to K982014.
STOCKERT S5 SYSTEM
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K022947 · Terumo Cardiovascular Systems Corp. · Mar 2003
AFFINITY BLOOD PUMP SYSTEM
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K943803 · Janus Biomedical, Inc. · Jan 1996
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K950990 · Stoeckert Instrumente · Jan 1996