Cleared Traditional

K922235 - SYSTEM 97

K922235 is the FDA 510(k) clearance for SYSTEM 97 by Datascope Corp.. It is a Class 2 Cardiovascular device (product code DSP) cleared through the Traditional 510(k) pathway after a 349-day FDA review.

K922235 · Datascope Corp. · Cardiovascular device
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Apr 1993
Decision
349d
Days
Class 2
Risk

K922235 is an FDA 510(k) clearance for the SYSTEM 97. 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 April 27, 1993 after a review of 349 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 K922235 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 1992
Decision Date April 27, 1993
Days to Decision 349 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
224d slower than avg
Panel avg: 125d · This submission: 349d
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 K922235.
DATASCOPE PERCOR STAT DL9.5 FR34CC INTRA-AORT BALL
K914802 · Datascope Corp. · Aug 1993
PERCOR STAT DL 9.5 FR 40CC INTRA-AORTIC BALLOON
K920427 · Datascope Corp. · Aug 1993
PEDIATRIC INTRA-AORTIC BALLOON CATHETERS
K905663 · Datascope Corp. · Aug 1993
BARD(R) INTRA AORTIC BALLOON
K924382 · C.R. Bard, Inc. · Apr 1993
SYSTEM 90 INTRA-AORTIC BALLOON PUMP CONSOLE
K921638 · Datascope Corp. · Feb 1993
DATASCOPE SYSTEM 95
K912629 · Datascope Corp. · Mar 1992