# Fisher and Paykel Healthcare Limited

- Location (FDA's records): Auckland, NZ
- FDA decisions: 4 (2017–2026): 4 510(k) clearances
- Product codes: CBK (1), MNT (1), BZD (1), BTT (1)
- 510(k) review time since 2016: median 119 days, against 183 for FDA's reviews in the same codes and years (2 of 3 faster)
- Predicates its devices cite: 4 (0 its own); citations of its devices by later devices: 2 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Fisher & Paykel Healthcare, Ltd.: 4 (https://510kreport.com/company/fisher-paykel-healthcare)

## Firms that cite its devices most
- Fisher & Paykel Healthcare, Ltd.: 2 (https://510kreport.com/company/fisher-paykel-healthcare)

## Its most-cited devices
- K173060: F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow Version (2018), cited by 1
- K170367: Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Large, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Medium, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Small, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Extra Small (2017), cited by 1

## Recent decisions
- K262268: Optiflow Oxygen Kit (AA484J) (Aug 27, 2026)
- K233829: Nova Micro Pillows Mask Small A Model (NVP1SA); Nova Micro Pillows Mask Medium A Model (NVP1MA); Nova Micro Pillows Mask Large A Model (NVP1LA); Nova Micro Pillows Mask Fit Pack/SML A Model (NVP1SMLA); Nova Micro Pillows Mask Small Sleep Lab A (NVP1SSLA); Nova Micro Pillows Mask Medium Sleep Lab A (NVP1MSLA); Nova Micro Pillows Mask Large Sleep Lab A (NVP1LSLA); Nova Micro Pillows Mask Fit Pack Sleep Lab A (NVP1SMLSLA) (Aug 23, 2024)
- K173060: F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow Version (Jan 25, 2018)
- K170367: Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Large, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Medium, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Small, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Extra Small (Aug 24, 2017)

Source page: https://510kreport.com/company/fisher-and-paykel-healthcare