510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K901335Substantially Equivalent

Aloka Ust-5514Dtu-7.5 Linear Doppler Transducer

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

K901335 is the FDA 510(k) clearance record for ALOKA UST-5514DTU-7.5 LINEAR DOPPLER TRANSDUCER, a class II device, cleared for Ge Medical Systems Information Technologies on under FDA product code DPW (Flowmeter, Blood, Cardiovascular). FDA records list 171 510(k) clearances for Ge Medical Systems Information Technologies, from to . As of , FDA records show no recalls naming K901335.

Clearance record

Decision date
Received
(141 days to decision)
Product code
DPW Flowmeter, Blood, Cardiovascular
Regulation
21 CFR 870.2100
Device class
Class II
Review panel
Cardiovascular
Applicant
Ge Medical Systems Information Technologies 61 Barnes Park Rd. N., Wallingford CT
Third party review
No

Clearances, product code DPW

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