Cleared Traditional

INTRA-AORTIC BALLOON PUMP MODEL KAAT (K875036) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K875036 · Kontron Instruments, Inc. · Cardiovascular device
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May 1988
Decision
163d
Days
Class 2
Risk

K875036 is an FDA 510(k) clearance for the INTRA-AORTIC BALLOON PUMP MODEL KAAT. Classified as System, Balloon, Intra-aortic And Control (product code DSP), Class II - Special Controls.

Submitted by Kontron Instruments, Inc. (Everett, US). The FDA issued a Cleared decision on May 18, 1988 after a review of 163 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3535 - 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 Kontron Instruments, Inc. devices

Submission Details

510(k) Number K875036 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 1987
Decision Date May 18, 1988
Days to Decision 163 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d slower than avg
Panel avg: 125d · This submission: 163d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DSP System, Balloon, Intra-aortic And Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3535
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 - DSP System, Balloon, Intra-aortic And Control

All 90
Devices cleared under the same product code (DSP) and FDA review panel - the closest regulatory comparables to K875036.
SIDEWINDER 40CC DL INTRA-AORTIC BALLOON CATHETER
K894942 · Boston Scientific Corp · Sep 1989
INTRA AORTIC BALLOON
K893243 · Datascope Corp. · Jun 1989
DATASCOPE PERCOR STAT-MIL 9.5 FR INTRA-AORTIC BALL
K880289 · Datascope Corp. · Jun 1988
SYSTEM 90 TRANSPORT
K863219 · Datascope Corp. · Jan 1987
DATASCOPE 8.5 FRENCH ELECTRODE INTRA-AORTIC BALLOO
K850482 · Datascope Corp. · Aug 1985
IABP #90 SYSTEM
K831235 · Datascope Corp. · Feb 1985