AIRVO 2 HUMIDIFIER, MYAIRVO 2 HUMIDIFIER— 510(k) K131895
Substantially EquivalentFisher & Paykel Healthcare, Ltd.
FDA 510(k) clearance K131895 for AIRVO 2 HUMIDIFIER, MYAIRVO 2 HUMIDIFIER, Substantially Equivalent on 2013-10-24. Applicant: Fisher & Paykel Healthcare, Ltd.. Device class: 2.
Clearance details
- Applicant
- Fisher & Paykel Healthcare, Ltd.
- Product code
- Code BTT
- Device class
- Class 2
- Regulation
- 21 CFR 868.5450
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Manukau, NZ
Recent devices under product code BTT
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view all- K250651 — OptiPAP Junior Flexi Tube US (OPTIPAPFUS) +10 more
- K252173 — F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits Size A (ONIV117A) +3 more
- K243917 — F&P Optiflow Air/Oxygen Flow Source
- K251611 — Optiflow+ Nasal Cannula - Small (OPT942) +5 more
- K233643 — F&P Airvo 3 NIV (PT311US)
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, through . 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 K131895
K-number listed on FDA's recall record- Z-0158-2026 — Airvo 2, REF: PT101US, and myAirvo 2, REF: PT100US, used with Disinfection Kit User Manual, REF: UI-185043723
- Z-1823-2024 — Airvo 2 Humidifier, REF: PT101US, and myAirvo 2 Humidifier, REF: PT100US
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K131895.
Data sourced from openFDA. This site is unofficial and independent of the FDA.