Cleared Traditional

K921638 - SYSTEM 90 INTRA-AORTIC BALLOON PUMP CONSOLE

K921638 is an FDA 510(k) clearance for SYSTEM 90 INTRA-AORTIC BALLOON PUMP CONSOLE, manufactured by Datascope Corp.. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K921638

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.

DSP Device Classification - Class 2, Special Controls

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 145
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
BELMONT MODEL PBP INTRA-AORTIC BALLOON PUMP
K915580 · Belmont Instrument Corp. · Oct 1992
DATASCOPE SYSTEM 95
K912629 · Datascope Corp. · Mar 1992
SYSTEM 90 AND SYSTEM 90T
K913847 · Datascope Corp. · Mar 1992