WATERPAP VALVE— 510(k) K110713

Name: FDA 510(k) clearance K110713
Creator: U.S. Food and Drug Administration
Published: 2011-09-12

Substantially Equivalent

Airways Development, LLC

FDA 510(k) clearance K110713 for WATERPAP VALVE, Substantially Equivalent on 2011-09-12. Applicant: Airways Development, LLC. Device class: 2.

Clearance details

Applicant: Airways Development, LLC
Product code: Code BYE
Device class: Class 2
Regulation: 21 CFR 868.5965
Advisory panel: Anesthesiology
Date received: 2011-03-15
Decision date: 2011-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cedar Knolls, NJ, US

Download summary PDF View on FDA.gov ↗

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K133210 — B&B BUBBLER2014-03-28
K122610 — PLAXTRON CPAP SYSTEM, MODEL CH-FFM-87XX/CH-FFM-88XX SERIES2013-08-05
K112546 — O_TWO CPAP SYSTEM2011-12-27

Adverse events under product code BYE

product code BYE

Death: 5
Total: 5

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K110713

K-number listed on FDA's recall record

Z-0552-2016 — Airways Development LLC WaterPAP Positive Airway Pressure Device Reference #WP-7700.Class II·Terminated·Airways Development LLC·20150924

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K110713.

Data sourced from openFDA. This site is unofficial and independent of the FDA.