Cleared Traditional

MODIFIED SMEC PERCUTANEOUS INTRA-AORTIC (K840037) - FDA 510(k) Clearance

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

K840037 · Smec, Inc. · Cardiovascular device
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Feb 1985
Decision
393d
Days
Class 2
Risk

K840037 is an FDA 510(k) clearance for the MODIFIED SMEC PERCUTANEOUS INTRA-AORTIC. Classified as System, Balloon, Intra-aortic And Control (product code DSP), Class II - Special Controls.

Submitted by Smec, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 1, 1985 after a review of 393 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 Smec, Inc. devices

Submission Details

510(k) Number K840037 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 1984
Decision Date February 01, 1985
Days to Decision 393 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
268d slower than avg
Panel avg: 125d · This submission: 393d
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 90
Devices cleared under the same product code (DSP) and FDA review panel - the closest regulatory comparables to K840037.
DATASCOPE 8.5 FRENCH ELECTRODE INTRA-AORTIC BALLOO
K850482 · Datascope Corp. · Aug 1985
IABP #90 SYSTEM
K831235 · Datascope Corp. · Feb 1985
PERCOR 9.5 FR IAB ON DATASCOPE CO2
K833828 · Datascope Corp. · Feb 1985
PECOR 8.5 FRENCH IAB ON A DATASCOPE
K831307 · Datascope Corp. · Nov 1983
FRENCH INTRA-AORTIC 9.5 BALLOON ON KON
K831397 · Datascope Corp. · Nov 1983
PERCOR INTRA-AORTIC BALLOON INSERTION
K823342 · Datascope Corp. · Jan 1983