510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K950607Substantially Equivalent

Ust-5268P-5 Transducer

Aloka Co., Ltd., Wallingford CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K950607 is the FDA 510(k) clearance record for UST-5268P-5 TRANSDUCER, a class II device, cleared for Aloka Co., Ltd. on under FDA product code KRK (Manometer, Blood-Pressure, Venous). FDA records list 35 510(k) clearances for Aloka Co., Ltd., from to . As of , FDA records show no recalls naming K950607.

Clearance record

Decision date
Received
(218 days to decision)
Product code
KRK Manometer, Blood-Pressure, Venous
Regulation
21 CFR 870.1140
Device class
Class II
Review panel
Cardiovascular
Applicant
Aloka Co., Ltd. 10 Fairfield Blvd., Wallingford CT
510(k) summary
Summary
Third party review
No

Clearances, product code KRK

Trailing 12 months

FDA records hold no clearances under product code KRK in the trailing twelve months.

FDA records show no clearances under product code KRK in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KRK, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260