510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K910153Substantially Equivalent

Ust-974-5 Convex Transducer

GE Medical Systems Information Technologies, Inc., Wallingford CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K910153 is the FDA 510(k) clearance record for UST-974-5 CONVEX TRANSDUCER, a class II device, cleared for Ge Medical Systems Information Technologies on under FDA product code KNG (Monitor, Ultrasonic, Fetal). FDA records list 171 510(k) clearances for Ge Medical Systems Information Technologies, from to . As of , FDA records show no recalls naming K910153.

Clearance record

Decision date
Received
(74 days to decision)
Product code
KNG Monitor, Ultrasonic, Fetal
Regulation
21 CFR 884.2660
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Ge Medical Systems Information Technologies 61 Barnes Park Rd. N., Wallingford CT
Third party review
No

Clearances, product code KNG

Trailing 12 months
1 clearance under product code KNG in the twelve months to November 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KNG, trailing twelve months
MonthClearances
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260