Cleared Traditional

K250002 - Smart Check O2 (MA0236)

K250002 is an FDA 510(k) clearance for Smart Check O2 (MA0236), manufactured by Life Spark Medical, LLC. The device is a Class 2 Anesthesiology device with product code CCL cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K250002 · Life Spark Medical, LLC · Anesthesiology device
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Apr 2025
Decision
112d
Days
Class 2
Risk

K250002 is an FDA 510(k) clearance for the Smart Check O2 (MA0236). Classified as Analyzer, Gas, Oxygen, Gaseous-phase (product code CCL), Class II - Special Controls.

Submitted by Life Spark Medical, LLC (Washington, US). The FDA issued a Cleared decision on April 24, 2025 after a review of 112 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1720 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Life Spark Medical, LLC devices

FDA 510(k) Submission Details - K250002

510(k) Number K250002 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 2025
Decision Date April 24, 2025
Days to Decision 112 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 140d · This submission: 112d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CCL Device Classification - Class 2, Special Controls

Product Code CCL Analyzer, Gas, Oxygen, Gaseous-phase
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1720
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - CCL Analyzer, Gas, Oxygen, Gaseous-phase

All 44
Devices cleared under the same product code (CCL) and FDA review panel - the closest regulatory comparables to K250002.
PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1)
K261389 · Salter Labs · Jul 2026
OxyMinder Pro (10310)
K251245 · Bio-Med Device, Inc. · Aug 2025
Maxtec MaxO2 ME+p
K221734 · Maxtec, LLC · Apr 2023
Percent Oxygen Sensors
K213933 · Careox, LLC · Aug 2022
OxyMinder
K213948 · Bio-Med Devices, Inc. · Mar 2022
Accu O2 Oxygen Analyzer
K173807 · Precision Medical, Inc. · May 2018