510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K954670Substantially Equivalent

Pressore Monitor

Cleveland Medical Devices, Inc., Cleveland OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K954670 is the FDA 510(k) clearance record for PRESSORE MONITOR, a class I device, cleared for Cleveland Medical Devices, Inc. on under FDA product code IKE (Transducer, Miniature Pressure). FDA records list 8 510(k) clearances for Cleveland Medical Devices, Inc., from to . As of , FDA records show no recalls naming K954670.

Clearance record

Decision date
Received
(20 days to decision)
Product code
IKE Transducer, Miniature Pressure
Regulation
21 CFR 890.1615
Device class
Class I
Review panel
Physical Medicine
Applicant
Cleveland Medical Devices, Inc. 11000 Cedar Ave., Cleveland OH
510(k) summary
Summary
Third party review
No

Clearances, product code IKE

Trailing 12 months

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

FDA records show no clearances under product code IKE in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code IKE, 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