What the supplied FDA record confirms about the Luna CPAP and Auto CPAP System

What does the FDA record confirm?

An FDA 510(k) database entry identifies the device as the Luna CPAP and Auto CPAP System and lists 3B Medical, Inc. as the applicant. The FDA recorded a substantially equivalent decision for 510(k) K153387 on September 8, 2016. The entry classifies the device as a non-continuous ventilator (respirator).[1]

The entry does not mention Luna G3 APAP, firmware problems, warning letters, complaint-handling findings, design changes, affected serial numbers, or a recall. It therefore cannot verify claims about any of those subjects.[1]

How do CPAP and APAP differ?

A CPAP machine provides constant air pressure through the mouth and/or nose to help keep the airways open during sleep. An APAP machine automatically adjusts the air pressure delivered during sleep.[2]

The National Heart, Lung, and Blood Institute advises patients to discuss with a healthcare provider which type of positive airway pressure machine is appropriate for them.[2]

What can this record establish about a user’s device?

The supplied 510(k) entry does not establish whether a particular device is affected by a safety issue. It provides no firmware version, serial-number range, manufacturing-date range, or distribution-date range associated with such an issue.[1]

Users seeking information about a specific machine can record its exact model and serial number and ask the device supplier, manufacturer, or treating sleep clinic whether any verified communication applies to it.

Follow-up during PAP treatment

The American Academy of Sleep Medicine states that adequate follow-up should occur after PAP therapy begins and during treatment of obstructive sleep apnea. Its guideline also says PAP treatment should be based on a diagnosis established through objective sleep apnea testing.[3]

This article provides general educational information and is not medical advice. Do not start, stop, or change CPAP therapy or settings without guidance from a qualified clinician.

Evidence limitation: The supplied FDA record supports only the details stated in its 510(k) database entry. It does not provide evidence about Luna G3 APAP safety communications or recall status.[1]

Sources

1. [1] 510(k) Premarket Notification K153387: Luna CPAP and Auto CPAP System — U.S. Food and Drug Administration
2. [2] Sleep Apnea Treatment — National Heart, Lung, and Blood Institute
3. [3] Clinical practice guideline on PAP therapy for sleep apnea — American Academy of Sleep Medicine