510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K071165Substantially Equivalent

Iscalert Sensor System

Alertis Medical AS, Findley MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K071165 is the FDA 510(k) clearance record for ISCALERT SENSOR SYSTEM, a class II device, cleared for Alertis Medical AS on under FDA product code CCC (Analyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling). FDA records list one 510(k) clearance for Alertis Medical AS. As of , FDA records show no recalls naming K071165.

Clearance record

Decision date
Received
(195 days to decision)
Product code
CCC Analyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling
Regulation
21 CFR 868.1150
Device class
Class II
Review panel
Anesthesiology
Applicant
Alertis Medical AS 6470 Riverview Ter., Findley MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code CCC

Trailing 12 months

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

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