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FDA 510(k)

PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1)

K-Number: K261389 · 2026-07-30

ApplicantSalter Labs
Decision Date2026-07-30
Product CodeCCL
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1) is the device name listed in this FDA 510(k) record. The listed applicant is Salter Labs. It received FDA 510(k) clearance on 2026-07-30 under 510(k) number K261389. The device is classified under product code CCL. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1)?

PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1) is a medical device that received FDA 510(k) clearance on 2026-07-30. The listed applicant is Salter Labs. The 510(k) number is K261389.

When did PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1) receive FDA 510(k) clearance?

PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1) received FDA 510(k) clearance on 2026-07-30, under 510(k) number K261389.

Who is the listed applicant for PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1)?

The FDA 510(k) record lists Salter Labs as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1)?

The FDA product code for PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1) is CCL.

Other records listing Salter Labs as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K190878Trach- Vac Endotracheal Tube (SFTVPU) Subglottic Suction Tube with Salter Flex-Tip and Salter ThinCuff, Trach- Vac Endotracheal Tube (SFTVVC) Subglottic Suction Tube with Salter Flex-Tip and Salter ThinCuffK161719Salter Labs Bubble HumidifierK151874BiNAPS Nasal Airflow and Snore Transducer; ThermiSense Oral/Nasal Thermal AirFlow Sensor with Airflow Pressure Cannulas, Nasal and Oral/NasalK151506Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen CannulaK151421Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2 Cannula, Sample Lines

Related Devices (Code: CCL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251245OxyMinder Pro (10310)Bio-Med Device, Inc.K250002Smart Check O2 (MA0236)Life Spark Medical, LLCK221734Maxtec MaxO2 ME+pMaxtec, LLCK213933Percent Oxygen SensorsCareox, LLCK213948OxyMinderBio-Med Devices, Inc.K173807Accu O2 Oxygen AnalyzerPrecision Medical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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