510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K250002Substantially Equivalent

Smart Check O2 (MA0236)

Life Spark Medical, Washington UT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K250002 is the FDA 510(k) clearance record for Smart Check O2 (MA0236), a class II device, cleared for Life Spark Medical, LLC on under FDA product code CCL (Analyzer, Gas, Oxygen, Gaseous-Phase). FDA records list one 510(k) clearance for Life Spark Medical, LLC. As of , FDA records show no recalls naming K250002.

Clearance record

Decision date
Received
(112 days to decision)
Product code
CCL Analyzer, Gas, Oxygen, Gaseous-Phase
Regulation
21 CFR 868.1720
Device class
Class II
Review panel
Anesthesiology
Applicant
Life Spark Medical, LLC 2430 W 350 N, Washington UT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code CCL

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