Cleared Traditional

MEDI-TRACE PHYSIOLOGICAL PRESSURE TRANS (K820457) - FDA 510(k) Clearance

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

K820457 · Graphic Controls Corp. · Cardiovascular device
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Mar 1982
Decision
21d
Days
Class 2
Risk

K820457 is an FDA 510(k) clearance for the MEDI-TRACE PHYSIOLOGICAL PRESSURE TRANS. Classified as Transducer, Blood-pressure, Extravascular (product code DRS), Class II - Special Controls.

Submitted by Graphic Controls Corp. (Mchenry, US). The FDA issued a Cleared decision on March 12, 1982 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2850 - 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 Graphic Controls Corp. devices

Submission Details

510(k) Number K820457 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 1982
Decision Date March 12, 1982
Days to Decision 21 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
104d faster than avg
Panel avg: 125d · This submission: 21d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DRS Transducer, Blood-pressure, Extravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2850
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 - DRS Transducer, Blood-pressure, Extravascular

All 16
Devices cleared under the same product code (DRS) and FDA review panel - the closest regulatory comparables to K820457.
PHYSIOLOGICAL PRESSURE TRANSDUCER 1290C
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CARDIOFAX ECG 6543
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USCI ELECTRONIC MANOMETER
K830093 · C.R. Bard, Inc. · Jan 1983
BARD CARDIOPULMONARY MONITORING LINES
K820186 · C.R. Bard, Inc. · Feb 1982
NIHON KOHDEN ELECTROCARDIOGRAPH
K813266 · Nihon Kohden America, Inc. · Jan 1982
CATHDAMP
K810661 · Medline Industries, Inc. · Mar 1981