Cleared Traditional

K803096 - NARCO TELECARE TRANSDUCER DOME #700-4000

K803096 is an FDA 510(k) clearance for NARCO TELECARE TRANSDUCER DOME #700-4000, manufactured by Narco Scientific. The device is a Class 2 Cardiovascular device with product code DRS cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K803096 · Narco Scientific · Cardiovascular device
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Jan 1981
Decision
36d
Days
Class 2
Risk

K803096 is an FDA 510(k) clearance for the NARCO TELECARE TRANSDUCER DOME #700-4000. Classified as Transducer, Blood-pressure, Extravascular (product code DRS), Class II - Special Controls.

Submitted by Narco Scientific (Mchenry, US). The FDA issued a Cleared decision on January 13, 1981 after a review of 36 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 Narco Scientific devices

FDA 510(k) Submission Details - K803096

510(k) Number K803096 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 1980
Decision Date January 13, 1981
Days to Decision 36 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
89d faster than avg
Panel avg: 125d · This submission: 36d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRS Device Classification - Class 2, Special Controls

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 91
Devices cleared under the same product code (DRS) and FDA review panel - the closest regulatory comparables to K803096.
COBE DISPOSABLE PRESSURE TRANSDUCER
K810637 · Cobe Laboratories, Inc. · Apr 1981
CATHDAMP
K810661 · Medline Industries, Inc. · Mar 1981
DISPOSABLE DIAPHRAGM DOME
K810009 · Medex, Inc. · Feb 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