510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K991884Substantially Equivalent

Siemens Fio2 Sensor

Siemens Medical Solutions USA, Inc., Danvers MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K991884 is the FDA 510(k) clearance record for SIEMENS FIO2 SENSOR, a class II device, cleared for Siemens Medical Solutions USA, Inc. on under FDA product code CCL (Analyzer, Gas, Oxygen, Gaseous-Phase). FDA records list 829 510(k) clearances for Siemens Medical Solutions USA, Inc., from to . As of , FDA records show no recalls naming K991884.

Clearance record

Decision date
Received
(154 days to decision)
Product code
CCL Analyzer, Gas, Oxygen, Gaseous-Phase
Regulation
21 CFR 868.1720
Device class
Class II
Review panel
Anesthesiology
Applicant
Siemens Medical Solutions USA, Inc. 16 Electronics Ave., Danvers MA
510(k) summary
Summary
Third party review
No

Clearances, product code CCL

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