Cleared Traditional

K921638 - SYSTEM 90 INTRA-AORTIC BALLOON PUMP CON...

K921638 is the FDA 510(k) clearance for SYSTEM 90 INTRA-AORTIC BALLOON PUMP CON... by Datascope Corp.. It is a Class 2 Cardiovascular device (product code DSP) cleared through the Traditional 510(k) pathway after a 310-day FDA review.

K921638 · Datascope Corp. · Cardiovascular device
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Feb 1993
Decision
310d
Days
Class 2
Risk

K921638 is an FDA 510(k) clearance for the SYSTEM 90 INTRA-AORTIC BALLOON PUMP CONSOLE. Classified as System, Balloon, Intra-aortic And Control (product code DSP), Class II - Special Controls.

Submitted by Datascope Corp. (Paramus, US). The FDA issued a Cleared decision on February 10, 1993 after a review of 310 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Datascope Corp. devices

Submission Details

510(k) Number K921638 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 1992
Decision Date February 10, 1993
Days to Decision 310 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
185d slower than avg
Panel avg: 125d · This submission: 310d
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 123
Devices cleared under the same product code (DSP) and FDA review panel - the closest regulatory comparables to K921638.
PEDIATRIC INTRA-AORTIC BALLOON CATHETERS
K905663 · Datascope Corp. · Aug 1993
SYSTEM 97
K922235 · Datascope Corp. · Apr 1993
BARD(R) INTRA AORTIC BALLOON
K924382 · C.R. Bard, Inc. · Apr 1993
DATASCOPE SYSTEM 95
K912629 · Datascope Corp. · Mar 1992
SYSTEM 90 AND SYSTEM 90T
K913847 · Datascope Corp. · Mar 1992
DATASCOPE PERCOR STAT INTRA-AORTIC BALLOON
K910997 · Datascope Corp. · Nov 1991