Cleared Traditional

KONTRON INTRA-AORTIC BALLOON PUMP, MODEL KAAT II (K905313) - FDA 510(k) Clearance

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

K905313 · Kontron Instruments, Inc. · Cardiovascular device
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Jun 1991
Decision
203d
Days
Class 2
Risk

K905313 is an FDA 510(k) clearance for the KONTRON INTRA-AORTIC BALLOON PUMP, MODEL KAAT II. 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 June 19, 1991 after a review of 203 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 K905313 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 1990
Decision Date June 19, 1991
Days to Decision 203 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
78d slower than avg
Panel avg: 125d · This submission: 203d
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 29
Devices cleared under the same product code (DSP) and FDA review panel - the closest regulatory comparables to K905313.
BSC/CA MODEL 930 IAB, BSC/CA 30 SIDEWINDER
K936232 · Boston Scientific Corp · Oct 1994
9.5 FR SIDEWINDER DL INTRA-AORTIC BALLON CATHETER
K926000 · Boston Scientific Corp · Aug 1993
BARD(R) INTRA AORTIC BALLOON
K924382 · C.R. Bard, Inc. · Apr 1993
SERIES 3001 IABP
K900281 · Boston Scientific Corp · Apr 1990
SIDEWINDER 40CC DL INTRA-AORTIC BALLOON CATHETER
K896920 · Boston Scientific Corp · Mar 1990
THE SIDEWINDER 40CC DL INTRA-AORTIC BALLOON CATH.
K896597 · Boston Scientific Corp · Feb 1990