510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K902654Substantially Equivalent

Cdi (Tm) System 100 Monitoring System

3M Company, Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K902654 is the FDA 510(k) clearance record for CDI (TM) SYSTEM 100 MONITORING SYSTEM, a class II device, cleared for 3M Health Care, Ltd. on under FDA product code DTY (Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass). FDA records list 58 510(k) clearances for 3M COMPANY, from to . As of , FDA records show 5 recalls naming K902654.

Clearance record

Decision date
Received
(143 days to decision)
Product code
DTY Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass
Regulation
21 CFR 870.4410
Device class
Class II
Review panel
Cardiovascular
Applicant
3M Health Care, Ltd. 2801 Barranca Rd., Irvine CA
Third party review
No

Clearances, product code DTY

Trailing 12 months

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

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