510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K864090Substantially Equivalent

Shelf Life Change of Sterile Devices

Utah Medical Products, Inc, Midvale UT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K864090 is the FDA 510(k) clearance record for SHELF LIFE CHANGE OF STERILE DEVICES, a class II device, cleared for Utah Medical Products, Inc. on under FDA product code DRS (Transducer, Blood-Pressure, Extravascular). FDA records list 38 510(k) clearances for Utah Medical Products, Inc., from to . As of , FDA records show no recalls naming K864090.

Clearance record

Decision date
Received
(178 days to decision)
Product code
DRS Transducer, Blood-Pressure, Extravascular
Regulation
21 CFR 870.2850
Device class
Class II
Review panel
Cardiovascular
Applicant
Utah Medical Products, Inc. 7043 S. 300 W., Midvale UT
Third party review
No

Clearances, product code DRS

Trailing 12 months
1 clearance under product code DRS in the twelve months to October 2026, September 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DRS, 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 20261
October 20260