PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1)
FDA 510(k) K261389 · Salter Labs
510(k) numberK261389
Submission
- Device name
- PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1)
- Applicant
- Salter Labs
El Paso, TX, US - Received
- April 28, 2026
- Decision date
- July 30, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CCL – Analyzer, Gas, Oxygen, Gaseous-Phase
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1720
- Specialty
- Anesthesiology
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|---|---|---|---|
| K251245 | OxyMinder Pro (10310)CCL · Traditional | Bio-Med Device, Inc. | 08/11/2025SE |
| K250002 | Smart Check O2 (MA0236)CCL · Traditional | Life Spark Medical, LLC | 04/24/2025SE |
| K221734 | Maxtec MaxO2 ME+pCCL · Traditional | Maxtec, LLC | 04/01/2023SE |
| K213933 | Percent Oxygen SensorsCCL · Traditional | Careox, LLC | 08/19/2022SE |
| K213948 | OxyMinderCCL · Traditional | Bio-Med Devices, Inc. | 03/17/2022SE |
| K173807 | Accu O2 Oxygen AnalyzerCCL · Abbreviated | Precision Medical, Inc. | 05/02/2018SE |
| K153659 | MaxO2MECCL · Traditional | Maxtec, LLC | 06/10/2016SE |
| K123195 | Carescape Respiratory Modules, E-Sco, E-Scov, E-Scaiov and AccessoriesCCL · Traditional | GE Healthcare Finland Oy | 02/28/2013SE |
| K122290 | Envitec Mysign O Oxygen Measuring DeviceCCL · Traditional | Envitec-Wismar GmbH | 01/23/2013SE |
| K112402 | ULTRAMAXO2 Oxygen AnalyerCCL · Abbreviated | Maxtec, LLC | 12/14/2011SE |
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| K151874 | BiNAPS Nasal Airflow and Snore Transducer; ThermiSense Oral/Nasal Thermal AirFlow Sensor…MNR · Traditional | 04/15/2016SE |
| K151506 | Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen CannulaNFB · Traditional | 03/11/2016SE |
| K151421 | Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2 Cannula…CCK · Traditional | 03/10/2016SE |
| K143700 | CPAP CannulaideBZD · Traditional | 08/05/2015SE |
| K142416 | Luma WrapPDH · Traditional | 06/12/2015SE |
| K092685 | Pneumotherml, Model: 5800BZQ · Special | 11/24/2009SE |
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Questions and answers
When was PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1) cleared by the FDA?
PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1) (K261389) received a 510(k) decision of Substantially Equivalent on July 30, 2026, 93 days after the submission was received.
What is the product code of K261389?
The FDA product code is CCL – Analyzer, Gas, Oxygen, Gaseous-Phase, a Class II (moderate risk) device regulated under 21 CFR 868.1720.