CPAP MASK— 510(k) K071915

Name: FDA 510(k) clearance K071915
Creator: U.S. Food and Drug Administration
Published: 2008-05-14

Substantially Equivalent

Arcimed Laboratories, LLC

FDA 510(k) clearance K071915 for CPAP MASK, Substantially Equivalent on 2008-05-14. Applicant: Arcimed Laboratories, LLC. Device class: 2.

Clearance details

Applicant: Arcimed Laboratories, LLC
Product code: Code BZD
Device class: Class 2
Regulation: 21 CFR 868.5905
Advisory panel: Anesthesiology
Date received: 2007-07-11
Decision date: 2008-05-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bonita Springs, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code BZD

view all

K253044 — RXiBreeze PAP System (RXiBreeze 20C)2026-07-23
K253553 — Orion2026-06-04
K254104 — ResScan Essentials2026-05-27
K251920 — Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face Mask2026-05-21
K253166 — F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)2026-04-29

Adverse events under product code BZD

product code BZD

Death: 4,440
Injury: 53,099
Malfunction: 213,222
Other: 17
Total: 270,778

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.