Cleared Traditional

K905000 - ALOKA UST-964P-5 ENDOVAGINAL TRANSDUCER

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

K905000 · Corometrics Medical Systems, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K905000

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 161d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HEM Device Classification - Class 2, Special Controls

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.
ABACUS OB ULTRASOUNG COMPUTER SOFTWARE
K951393 · Solomon Technology Labs · May 1995
BABE COMPUTER POGRAM FOR OBSTETRIC ULTRASOUND
K942490 · Medical Soft, Inc. · Feb 1995
SDU 500 DIAGNOSTIC ULTRASOUND INSTRUMENT
K910426 · Shimadzu Medical Systems · Jun 1991
SONOACE 88 PORTABLE ULTRASOUND SCANNER
K900505 · Medison Co., Ltd. · Aug 1990
MODEL OB-500 FETAL GROWTH ANALYSIS & OPTION OBLINK
K900271 · Digisonics, Inc. · Apr 1990
EXTENDED OBSTETRICS SOFTWARE COMPUTATION PACKAGE
K890637 · Elscint, Inc. · Jun 1989
K905000 · ALOKA UST-964P-5 ENDOVAGINAL TRANSDUCER
Download PDF Corometrics Medical S…