Cleared Traditional

K910153 - UST-974-5 CONVEX TRANSDUCER (FDA 510(k) Clearance)

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

K910153 · Ge Medical Systems Information Technologies · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1991
Decision
74d
Days
Class 2
Risk

K910153 is an FDA 510(k) clearance for the UST-974-5 CONVEX TRANSDUCER. Classified as Monitor, Ultrasonic, Fetal (product code KNG), Class II - Special Controls.

Submitted by Ge Medical Systems Information Technologies (Wallingford, US). The FDA issued a Cleared decision on March 29, 1991 after a review of 74 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.2660 - 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 Ge Medical Systems Information Technologies devices

Submission Details

510(k) Number K910153 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 1991
Decision Date March 29, 1991
Days to Decision 74 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
86d faster than avg
Panel avg: 160d · This submission: 74d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KNG Monitor, Ultrasonic, Fetal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.2660
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 - KNG Monitor, Ultrasonic, Fetal

All 59
Devices cleared under the same product code (KNG) and FDA review panel - the closest regulatory comparables to K910153.
Fetal Doppler U8-25, U9-25
K252669 · Zhongshan Xiaolan Town Senlan Electronic Factory · Jan 2026
Doppler FHR Detector (BF-500D+, BF-560)
K242846 · Shenzhen Bestman Instrument Co., Ltd. · Jun 2025
Ultrasonic Fetal Doppler
K233823 · Shenzhen Jamr Technology Co., Ltd. · Jun 2024
Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fetal Doppler (CONTEC 10F)
K232893 · Contec Medical Systems Co.,Ltd · Jun 2024
Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL)
K220245 · Contec Medical Systems Co.,Ltd · Sep 2022
Fetal Doppler
K211940 · Shenzhen Taikang Medical Equipment Co., Ltd. · Jan 2022