Cleared Traditional

K840367 - PRESSURE TRIGGER MOD OF SMEC INTRA-AORT

K840367 is an FDA 510(k) clearance for PRESSURE TRIGGER MOD OF SMEC INTRA-AORT, manufactured by Smec, Inc.. The device is a Class 2 Cardiovascular device with product code DSP cleared through the Traditional 510(k) pathway after a 684-day FDA review.

K840367 · Smec, Inc. · Cardiovascular device
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Dec 1985
Decision
684d
Days
Class 2
Risk

K840367 is an FDA 510(k) clearance for the PRESSURE TRIGGER MOD OF SMEC INTRA-AORT. Classified as System, Balloon, Intra-aortic And Control (product code DSP), Class II - Special Controls.

Submitted by Smec, Inc.. The FDA issued a Cleared decision on December 11, 1985 after a review of 684 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Smec, Inc. devices

FDA 510(k) Submission Details - K840367

510(k) Number K840367 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 1984
Decision Date December 11, 1985
Days to Decision 684 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
559d slower than avg
Panel avg: 125d · This submission: 684d
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 148
Devices cleared under the same product code (DSP) and FDA review panel - the closest regulatory comparables to K840367.
NOVEMPERC DOUBLE LUMEN INTRA-AORTIC BALLOON
K860638 · Kontron Instruments, Inc. · Oct 1986
KONTRON INTRA-AORTIC BALLOON PUMP MODEL KAAT
K860427 · Kontron Instruments, Inc. · May 1986
INTRA-AORTIC BALLOON PUMP MODEL K2000
K853062 · Kontron Instruments, Inc. · Jan 1986
DATASCOPE 8.5 FRENCH ELECTRODE INTRA-AORTIC BALLOO
K850482 · Datascope Corp. · Aug 1985
ARIES MEDICAL PERFLEX PERCUTANEOUS 40CC D/L BALLOO
K844220 · Aries Medical, Inc. · Feb 1985
IABP #90 SYSTEM
K831235 · Datascope Corp. · Feb 1985