510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K260438Substantially Equivalent

Vital Signs Monitor (CLEO2)

Infinium Medical, Inc, Largo FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K260438 is the FDA 510(k) clearance record for Vital Signs Monitor (CLEO2), a class II device, cleared for Infinium Medical, Inc. on under FDA product code MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)). FDA records list 7 510(k) clearances for Infinium Medical, Inc., from to . As of , FDA records show no recalls naming K260438.

Clearance record

Decision date
Received
(184 days to decision)
Product code
MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Regulation
21 CFR 870.2300
Device class
Class II
Review panel
Cardiovascular
Applicant
Infinium Medical, Inc. 12151 62nd St. N. #5, Largo FL
510(k) summary
Statement
Third party review
No

Clearances, product code MWI

Trailing 12 months
5 clearances under product code MWI in the twelve months to October 2026, August 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code MWI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20261
May 20260
June 20261
July 20260
August 20262
September 20260
October 20260