Cleared Traditional

SMEC BALLOON SYSTEM (K823177) - FDA 510(k) Clearance

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

K823177 · Smec, Inc. · Cardiovascular device
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Dec 1982
Decision
50d
Days
Class 2
Risk

K823177 is an FDA 510(k) clearance for the SMEC BALLOON SYSTEM. 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 December 15, 1982 after a review of 50 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Smec, Inc. devices

Submission Details

510(k) Number K823177 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 1982
Decision Date December 15, 1982
Days to Decision 50 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 125d · This submission: 50d
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 K823177.
FRENCH INTRA-AORTIC 9.5 BALLOON ON KON
K831397 · Datascope Corp. · Nov 1983
PERCOR INTRA-AORTIC BALLOON INSERTION
K823342 · Datascope Corp. · Jan 1983
DATASCOPE MODEL 83 IABP SYSTEM
K821951 · Datascope Corp. · Dec 1982
PECOR, PERCOR-DL, 10.5 FRENCH W/SMEC
K820882 · Datascope Corp. · Oct 1982
DATASCOPE 10.5 FRENCH INTRA-AORTIC BAL
K821065 · Datascope Corp. · Aug 1982
DATASCOPE MODIFIED #82 IABP SYSTEM
K813182 · Datascope Corp. · Mar 1982