MERCURY MEDICAL PEEP VALVE— 510(k) K081266

Name: FDA 510(k) clearance K081266
Creator: U.S. Food and Drug Administration
Published: 2009-03-05

Substantially Equivalent

Mercury Enterprizes Dba Mercury Medical

FDA 510(k) clearance K081266 for MERCURY MEDICAL PEEP VALVE, Substantially Equivalent on 2009-03-05. Applicant: Mercury Enterprizes Dba Mercury Medical. Device class: 2.

Clearance details

Applicant: Mercury Enterprizes Dba Mercury Medical
Product code: Code BYE
Device class: Class 2
Regulation: 21 CFR 868.5965
Advisory panel: Anesthesiology
Date received: 2008-05-05
Decision date: 2009-03-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clearwater, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code BYE

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K160112 — Besmed PEEP Valve2016-04-29
K133957 — DISPOSABLE ADJUSTABLE PEEP VALVE MR CONDITIONAL USE2014-04-14
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 →

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