Cleared Traditional

K922235 - SYSTEM 97

K922235 is an FDA 510(k) clearance for SYSTEM 97, 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 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

FDA 510(k) Submission Details - K922235

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.

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 K922235.
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PERCOR STAT DL 9.5 FR 40CC INTRA-AORTIC BALLOON
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PEDIATRIC INTRA-AORTIC BALLOON CATHETERS
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K924382 · C.R. Bard, Inc. · Apr 1993
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K921638 · Datascope Corp. · Feb 1993
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K915580 · Belmont Instrument Corp. · Oct 1992