Cleared Traditional

K905000 - ALOKA UST-964P-5 ENDOVAGINAL TRANSDUCER

K905000 is the FDA 510(k) clearance for ALOKA UST-964P-5 ENDOVAGINAL TRANSDUCER by Corometrics Medical Systems, Inc.. It is a Class 2 Obstetrics & Gynecology device (product code HEM) cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K905000 · Corometrics Medical Systems, Inc. · Obstetrics & Gynecology device
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Jan 1991
Decision
85d
Days
Class 2
Risk

K905000 is an FDA 510(k) clearance for the ALOKA UST-964P-5 ENDOVAGINAL TRANSDUCER. Classified as Imager, Ultrasonic Obstetric-gynecologic (product code HEM), Class II - Special Controls.

Submitted by Corometrics Medical Systems, Inc. (Wallingford, US). The FDA issued a Cleared decision on January 31, 1991 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.2225 - the FDA obstetrics and gynecology device 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 Corometrics Medical Systems, Inc. devices

Submission Details

510(k) Number K905000 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 1990
Decision Date January 31, 1991
Days to Decision 85 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 160d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HEM Imager, Ultrasonic Obstetric-gynecologic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.2225
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 Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HEM Imager, Ultrasonic Obstetric-gynecologic

All 15
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