Cleared Traditional

K261389 - PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1)

K261389 is an FDA 510(k) clearance for PRO2 Elite Plus Oxygen Analyzer (PRO2PL..., manufactured by Salter Labs. The device is a Class 2 Anesthesiology device with 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

FDA 510(k) Submission Details - K261389

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.

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 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 65
Devices cleared under the same product code (CCL) and FDA review panel - the closest regulatory comparables to K261389.
OxyMinder Pro (10310)
K251245 · Bio-Med Device, Inc. · Aug 2025
Smart Check O2 (MA0236)
K250002 · Life Spark Medical, LLC · Apr 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