Cleared Traditional

K810009 - DISPOSABLE DIAPHRAGM DOME

K810009 is the FDA 510(k) clearance for DISPOSABLE DIAPHRAGM DOME by Medex, Inc.. It is a Class 2 Cardiovascular device (product code DRS) cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K810009 · Medex, Inc. · Cardiovascular device
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Feb 1981
Decision
45d
Days
Class 2
Risk

K810009 is an FDA 510(k) clearance for the DISPOSABLE DIAPHRAGM DOME. Classified as Transducer, Blood-pressure, Extravascular (product code DRS), Class II - Special Controls.

Submitted by Medex, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 19, 1981 after a review of 45 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 Medex, Inc. devices

Submission Details

510(k) Number K810009 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 1981
Decision Date February 19, 1981
Days to Decision 45 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 125d · This submission: 45d
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 70
Devices cleared under the same product code (DRS) and FDA review panel - the closest regulatory comparables to K810009.
PHYSIOLOGICAL PRESSURE TRANSDUCER
K812758 · Electromedics, Inc. · Oct 1981
COBE DISPOSABLE PRESSURE TRANSDUCER
K810637 · Cobe Laboratories, Inc. · Apr 1981
CATHDAMP
K810661 · Medline Industries, Inc. · Mar 1981
CARDIOSCOPE J200
K802179 · Telectronics, Inc. · Nov 1980
ACCUDYNAMIC
K801048 · Sorensen Research · May 1980
MEDI-TRACE TRANSDUCERS/PHYSIOLOG. MONITO
K800705 · Graphic Controls Corp. · Apr 1980