Optiflow+ Nasal Cannula - Small (OPT942) +5 more— 510(k) K251611

Clearance details

Device name as filed

Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT944); Optiflow+ Nasal Cannula - Large (OPT946); Optiflow+ Nasal Cannula Small (MYOPT9SMALL); Optiflow+ Nasal Cannula Medium (MYOPT9MEDIUM); Optiflow+ Nasal Cannula Large (MYOPT9LARGE)

Applicant

Fisher & Paykel Healthcare, Ltd.

Product code

Code BTT

Device class

Class 2

Regulation

21 CFR 868.5450

Advisory panel

Anesthesiology

Date received

2025-05-27

Decision date

2025-06-25

Decision

Substantially Equivalent

Clearance type

Special

Location

Auckland, NZ

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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 →