Cleared Traditional

K905369 - UST-2266U-5 CW DOPPLER TRANSDUCER

K905369 is an FDA 510(k) clearance for UST-2266U-5 CW DOPPLER TRANSDUCER, manufactured by Ge Medical Systems Information Technologies. The device is a Class 2 Cardiovascular device with product code JOP cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K905369 · Ge Medical Systems Information Technologies · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1991
Decision
74d
Days
Class 2
Risk

K905369 is an FDA 510(k) clearance for the UST-2266U-5 CW DOPPLER TRANSDUCER. Classified as Transducer, Ultrasonic (product code JOP), Class II - Special Controls.

Submitted by Ge Medical Systems Information Technologies (Wallingford, US). The FDA issued a Cleared decision on February 11, 1991 after a review of 74 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2880 - 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 Ge Medical Systems Information Technologies devices

FDA 510(k) Submission Details - K905369

510(k) Number K905369 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 1990
Decision Date February 11, 1991
Days to Decision 74 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
51d faster than avg
Panel avg: 125d · This submission: 74d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JOP Device Classification - Class 2, Special Controls

Product Code JOP Transducer, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2880
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 - JOP Transducer, Ultrasonic

All 36
Devices cleared under the same product code (JOP) and FDA review panel - the closest regulatory comparables to K905369.
Falcon/Xpress (Falcon/Xpress)
K242662 · Viasonix , Ltd. · Dec 2024
VasoGuard (V10, V8, V6, V4, V2)
K233976 · Corvascular Diagnostics, LLC · Jul 2024
CARDIAC COMPUTATION SOFTWARE PACKAGE
K890636 · Elscint, Inc. · Aug 1989
VOLUME COMPUTATION SOFTWARE PACKAGE
K890638 · Elscint, Inc. · Aug 1989
RESUBMITTAL OF MI 1000C MICROIMAGER
K881979 · Ausonics Pty , Ltd. · Jun 1989
TRANSESOPHAGEAL ECHO TRANSDUCER
K883889 · General Electric Co. · Nov 1988