510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K890010Substantially Equivalent

Cm 7000Mr

Trudell Medical, Ontario, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K890010 is the FDA 510(k) clearance record for CM 7000MR, a class II device, cleared for Trudell Medical on under FDA product code CAP (Monitor, Airway Pressure (Includes Gauge And/Or Alarm)). FDA records list 3 510(k) clearances for Trudell Medical, from to . As of , FDA records show no recalls naming K890010.

Clearance record

Decision date
Received
(160 days to decision)
Product code
CAP Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
Regulation
21 CFR 868.2600
Device class
Class II
Review panel
Anesthesiology
Applicant
Trudell Medical 926 Leathorne St., London, Ontario, CA
Third party review
No

Clearances, product code CAP

Trailing 12 months

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

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