Cleared Traditional

ALOKA UST-964P-5 ENDOVAGINAL TRANSDUCER (K905000) - FDA 510(k) Clearance

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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 29
Devices cleared under the same product code (HEM) and FDA review panel - the closest regulatory comparables to K905000.
SIEMENS INTRAVAGINAL TRANSDUCER
K885061 · Siemens Medical Solutions USA, Inc. · Feb 1989
5 MHZ INTRACAVITARY PROBE, MODEL H4222V
K860233 · General Electric Co. · Jun 1986
5.0 MHZ INTRACAVITARY SECTOR PROBE
K853711 · General Electric Co. · Dec 1985
DATASON DB ULTRASOUND IMAGING SYSTEM
K810305 · General Electric Co. · Mar 1981
V.I. OCTOSON ULTRASONIC SYSTEM
K760874 · General Electric Co. · Dec 1976