ReddyPort Elbow Device Gets FDA Clearance

• By Laurie Watanabe
• Jul 27, 2023

The ReddyPort elbow device used for non-invasive ventilation (NIV) has received 510(k) premarket clearance from the U.S. Food & Drug Administration.

In a July 18 announcement, ReddyPort’s CEO, Tony Lair, said, “ReddyPort's patented elbow is central to the ecosystem we are building to help mitigate clinical obstacles tied to NIV therapy, from dry-mouth, oral biofilm accumulation to speech recognition.”

The announcement described the elbow as featuring “a self-sealing valve that provides seamless oral access to the patient's mouth without the need for mask removal, alleviating the risk of therapeutic pressure loss and maintaining lung compliance. With ReddyPort's elbow, bedside clinicians are empowered to use ReddyPort's oral care appliances (toothbrush, Yankauer, suction swab and applicator swabs) for routine Q2/Q4 oral care and dry mouth relief while minimizing unplanned mask removal that often leads to improperly fitted masks, pressure injuries and time-consuming refitting processes.”

The company added that the elbow “enables patients and clinicians to use the ReddyPort microphone. The ReddyPort microphone amplifies audible speech tones while minimizing background noise, helping patients to regain their ability to effectively communicate with caregivers and family members. The Joint Commission, supported by the Patient's Bill of Rights, incentivizes clinicians to protect every patient's ability to communicate with family members and caregivers as an essential part of quality patient care.”