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Airways Development, LLC

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Airways Development, LLC is a medical device manufacturer, with 5 devices listed in FDA GUDID and FDA 510(k) (FDA Class II) and 1 FDA recall as of 14 Nov 2026.

Devices
5
FDA recalls
1

Registry facts

Counted by deviCERTS from registry records, 14 Nov 2026

Registries
  • FDA GUDID 4
  • FDA 510(k) 1

A device listed in two registries counts in both.

Device classes
  • FDA Class II 5
FDA recalls

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Airways Development, LLC makes

Airways Development, LLC manufactures single-use mechanical expiratory valves designed for respiratory therapy, including kits and standalone devices for use in non-invasive ventilation and airway management. Products include the WaterPAP Starter Kit, WaterPAP PRO, WaterPAP PRO Starter Kit, WaterPAP, and the WATERPAP VALVE, which facilitate exhalation pressure relief in medical settings.

These devices are classified as Class II under FDA regulations and are authorised via 510(k) clearance and listed under the FDA’s Unique Device Identifier (UDI) system. The company operates from the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue5

Newest first, rows 1-5 of 5

FDA recalls1

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

FDA recall records list 1 recall initiated by Airways Development, LLC, initiated on 2015-09-24. By recorded status: 1 terminated. The reasons filed fall into these groups: mechanical integrity and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

  • 2015

    • 24 Sep 2015 Z-0552-2016 Class II Terminated Airways Development LLC has received a complaint about a canister leaking from WaterPAP Lot 8605A. During a review with their supplier it could not be determined if this was an isolated incident or if the whole lot is impacted. Distribution: Nationwide Submission number: K110713

Frequently asked questions

How many devices does Airways Development, LLC have in the registry?

The registry currently lists 5 devices for Airways Development, LLC. Devices recorded under merged duplicate company entries are counted once.

Which registries list Airways Development, LLC's devices?

Among its 5 most recently registered devices, Airways Development, LLC has devices listed in FDA 510(k) (1 device) and FDA GUDID (4 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Airways Development, LLC's devices fall under?

Among its 5 most recently registered devices, the classes recorded for Airways Development, LLC's devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Airways Development, LLC?

FDA recall records list 1 recall initiated by Airways Development, LLC, the most recent initiated on 24 Sep 2015. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Airways Development, LLC in the registry?

The most recently registered devices listed for Airways Development, LLC include WaterPAP Starter Kit WP-7705, WaterPAP PRO WP-7800, WaterPAP PRO Starter Kit WP-7805 and WaterPAP WP-7700.

Generated automatically from registry data and not verified by a human reviewer.