510(k) Report

FDA applicant

Fisher and Paykel Healthcare Limited

Auckland, NZ4 decisions2017–20260 recalls

FDA records 4 decisions for Fisher and Paykel Healthcare Limited (Auckland, NZ) from 2017 to 2026: 4 510(k) clearances. Most are in product codes CBK (Ventilator, Continuous, Facility Use) and MNT (Continuous, Minimal Ventilatory Support…). Since 2016 its 510(k)s took a median of 119 days from receipt to decision, against 183 for FDA’s reviews in the same codes and years. Its devices cite 4 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, anesthesiology panel, where it files most

How often FDA has decided Fisher and Paykel Healthcare Limited’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2017: 12018: 12024: 12026 (partial year): 1
2017high 1 (2017) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Fisher and Paykel Healthcare Limited by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Fisher and Paykel Healthcare Limited’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • CBKVentilator, Continuous, Facility Use1decision
  • MNTContinuous, Minimal Ventilatory Support, Facility Use Ventilator1decision
  • BZDVentilator, Non-Continuous (Respirator)1decision
  • BTTHumidifier, Respiratory Gas, (Direct Patient Interface)1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 119 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 183 days; 2 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K173060F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow VersionFisher and Paykel Healthcare Limited · 20181cites it
  • K170367Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Large, Nivairo RT045 Non-Vented…Fisher and Paykel Healthcare Limited · 20171cites it

What has FDA decided for it lately?

  • K262268Optiflow Oxygen Kit (AA484J)Fisher and Paykel Healthcare Limited · 2026
  • K233829Nova Micro Pillows Mask Small A Model (NVP1SA); Nova Micro Pillows Mask Medium A Model (NVP1MA); Nova Micro…Fisher and Paykel Healthcare Limited · 2024
  • K173060F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow VersionFisher and Paykel Healthcare Limited · 2018
  • K170367Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Large, Nivairo RT045 Non-Vented…Fisher and Paykel Healthcare Limited · 2017

All 4 as Fisher and Paykel Healthcare Limited →

Other applicant names beginning “Fisher”

FDA records each applicant name separately; these may or may not be the same firm.

Fisher Scientific Co., LLC 90Fisher & Paykel Healthcare, Ltd. 83Fisher & Paykel Electronics, Ltd. 17Fisher Diagnostics 16Fisher & Paykel Allied Products, Ltd. 12Fisher Imaging Corp. 3Fisher Price 2