510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K901548Substantially Equivalent

Biomedical Sensors-Shiley Bgm 4000 Intra Blood Gas

Shiley, Inc., Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K901548 is the FDA 510(k) clearance record for BIOMEDICAL SENSORS-SHILEY BGM 4000 INTRA BLOOD GAS, a class II device, cleared for Shiley, Inc. on under FDA product code CCC (Analyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling). FDA records list 174 510(k) clearances for Shiley, Inc., from to . As of , FDA records show no recalls naming K901548.

Clearance record

Decision date
Received
(286 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
Shiley, Inc. 17600 Gillette Ave., Irvine CA
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