O2asis Personal Oxygen Humidifier— 510(k) K193411

Name: FDA 510(k) clearance K193411
Creator: U.S. Food and Drug Administration
Published: 2020-11-12

Substantially Equivalent

Perma Pure, LLC

FDA 510(k) clearance K193411 for O2asis Personal Oxygen Humidifier, Substantially Equivalent on 2020-11-12. Applicant: Perma Pure, LLC. Device class: 2.

Clearance details

Applicant: Perma Pure, LLC
Product code: Code BTT
Device class: Class 2
Regulation: 21 CFR 868.5450
Advisory panel: Anesthesiology
Date received: 2019-12-09
Decision date: 2020-11-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lakewood, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code BTT

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K262268 — Optiflow Oxygen Kit (AA484J)2026-08-27
K254078 — HVT 2.02026-04-13
K251448 — FL-10000U Respiratory Humidifier2026-01-16
K251419 — Laboratorios Biogalenic Sterile Water for Inhalation, USP2026-01-14
K253479 — Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J)2025-12-19

Adverse events under product code BTT

product code BTT

Death: 60
Injury: 152
Malfunction: 7,232
Other: 2
Total: 7,446

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.