Cleared Traditional

K792020 - AE 840 PHYSIOLOGICAL PRESSURE TRANSDUCER

K792020 is the FDA 510(k) clearance for AE 840 PHYSIOLOGICAL PRESSURE TRANSDUCER by Life Medical Services, Inc.. It is a Class 2 Cardiovascular device (product code DRS) cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K792020 · Life Medical Services, Inc. · Cardiovascular device
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Dec 1979
Decision
59d
Days
Class 2
Risk

K792020 is an FDA 510(k) clearance for the AE 840 PHYSIOLOGICAL PRESSURE TRANSDUCER. Classified as Transducer, Blood-pressure, Extravascular (product code DRS), Class II - Special Controls.

Submitted by Life Medical Services, Inc. (Walker, US). The FDA issued a Cleared decision on December 7, 1979 after a review of 59 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 Life Medical Services, Inc. devices

Submission Details

510(k) Number K792020 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 1979
Decision Date December 07, 1979
Days to Decision 59 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 125d · This submission: 59d
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 86
Devices cleared under the same product code (DRS) and FDA review panel - the closest regulatory comparables to K792020.
ACCUDYNAMIC
K801048 · Sorensen Research · May 1980
MEDI-TRACE TRANSDUCERS/PHYSIOLOG. MONITO
K800705 · Graphic Controls Corp. · Apr 1980
MEDI-TRACE DISPOSABLE DOMES/MONITORING
K800706 · Graphic Controls Corp. · Apr 1980
MODEL 1979 BLOOD PRESSUROMETER R CHARTER
K792073 · Del Mar Avionics · Nov 1979
ACCUNAMIC
K791636 · Sorensen Research · Oct 1979
MICROTEC BACTERIAL FILTER
K790407 · Medex, Inc. · May 1979