Cleared Traditional

K801239 - STERILE

K801239 is the FDA 510(k) clearance for STERILE by Pacific Domes, Inc.. It is a Class 2 Cardiovascular device (product code DRS) cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K801239 · Pacific Domes, Inc. · Cardiovascular device
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Jul 1980
Decision
48d
Days
Class 2
Risk

K801239 is an FDA 510(k) clearance for the STERILE, DISP DOME, INDIVID. PKG.. Classified as Transducer, Blood-pressure, Extravascular (product code DRS), Class II - Special Controls.

Submitted by Pacific Domes, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 14, 1980 after a review of 48 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 Pacific Domes, Inc. devices

Submission Details

510(k) Number K801239 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 1980
Decision Date July 14, 1980
Days to Decision 48 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 125d · This submission: 48d
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 85
Devices cleared under the same product code (DRS) and FDA review panel - the closest regulatory comparables to K801239.
DISPOSABLE DIAPHRAGM DOME
K810009 · Medex, Inc. · Feb 1981
NARCO TELECARE TRANSDUCER DOME #700-4000
K803096 · Narco Scientific · Jan 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
MEDI-TRACE DISPOSABLE DOMES/MONITORING
K800706 · Graphic Controls Corp. · Apr 1980