Cleared Traditional

K261389 - PRO2 Elite Plus Oxygen Analyzer (PRO2PL...

K261389 is the FDA 510(k) clearance for PRO2 Elite Plus Oxygen Analyzer (PRO2PL... by Salter Labs. It is a Class 2 Anesthesiology device (product code CCL) cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K261389 · Salter Labs · Anesthesiology device
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Jul 2026
Decision
93d
Days
Class 2
Risk

K261389 is an FDA 510(k) clearance for the PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1). Classified as Analyzer, Gas, Oxygen, Gaseous-phase (product code CCL), Class II - Special Controls.

Submitted by Salter Labs (El Paso, US). The FDA issued a Cleared decision on July 30, 2026 after a review of 93 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 Salter Labs devices

Submission Details

510(k) Number K261389 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 2026
Decision Date July 30, 2026
Days to Decision 93 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
47d faster than avg
Panel avg: 140d · This submission: 93d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Consultant

Airlife Finland OY
Tanja-Maria Ranta

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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

All 33
Devices cleared under the same product code (CCL) and FDA review panel - the closest regulatory comparables to K261389.
OxyMinder Pro (10310)
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Smart Check O2 (MA0236)
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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