Cleared Traditional

PRESSURE MONITORING EXTENSION (K942482) - FDA 510(k) Clearance

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

K942482 · Surgical Technologies, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Jun 1994
Decision
20d
Days
Class 2
Risk

K942482 is an FDA 510(k) clearance for the PRESSURE MONITORING EXTENSION. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Surgical Technologies, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on June 14, 1994 after a review of 20 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - 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 Surgical Technologies, Inc. devices

Submission Details

510(k) Number K942482 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 1994
Decision Date June 14, 1994
Days to Decision 20 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
105d faster than avg
Panel avg: 125d · This submission: 20d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQO Catheter, Intravascular, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
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 - DQO Catheter, Intravascular, Diagnostic

All 153
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K942482.
CARDIAC CATHETERIZATION KIT
K932141 · Abbott Laboratories · Sep 1994
CORDIS STEADFAST MAGNETIC EXCHANGE SYSTEM
K942939 · Cordis Corp. · Aug 1994
HAND CONTROLLED SYRINGE
K942329 · Abbott Laboratories · Jun 1994
DYE MANAGEMENT SYSTEM
K941254 · Abbott Laboratories · Jun 1994
TRANSIT INFUSION CATHETER
K936260 · Cordis Corp. · May 1994
DYE MANAGEMENT SYSTEM
K933700 · Abbott Laboratories · Nov 1993