510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K890921Substantially Equivalent

Data Exchange System, Model 24

Siemens Life Support Systems, Schaumberg IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K890921 is the FDA 510(k) clearance record for DATA EXCHANGE SYSTEM, MODEL 24, a class II device, cleared for Siemens Life Support Systems on under FDA product code CBK (Ventilator, Continuous, Facility Use). FDA records list 6 510(k) clearances for Siemens Life Support Systems, from to . As of , FDA records show no recalls naming K890921.

Clearance record

Decision date
Received
(104 days to decision)
Product code
CBK Ventilator, Continuous, Facility Use
Regulation
21 CFR 868.5895
Device class
Class II
Review panel
Anesthesiology
Applicant
Siemens Life Support Systems P.O. Box 68517, Schaumberg IL
Third party review
No

Clearances, product code CBK

Trailing 12 months
4 clearances under product code CBK in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code CBK, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20261
April 20261
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260