Fisher & Paykel Healthcare, Ltd. (manufacturer, EAST TAMAKI Auckland, NZ): 1 new FDA device listing, incl. humidifier, respiratory gas, (direct patient interface)
Fisher & Paykel Healthcare, Ltd. (EAST TAMAKI Auckland): 1 new FDA device listing, incl. humidifier, respiratory gas, (direct patient interface). Its amount of 1 is above the median of 2 (50th percentile). Dated 66 days ago, it serves as a historical benchmark. Score 60/100. As of 2026-11-04, from openFDA device registration and listing endpoint (U.S. Food and Drug Administration).
Data as of · Compiled by Zalwin from openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
amount: 1 · 50th percentile of 2,709 DeviceEstablishmentPulse records · 0.5x the median
Free preview: all 15 published fields of this record are shown below. Locked: 3 related NZ DeviceEstablishmentPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Establishment | Fisher & Paykel Healthcare, Ltd. |
| Owner / operator | Fisher & Paykel Healthcare Nz Ltd |
| Role | Manufacturer |
| Establishment types | Complaint File Establishment per 21 CFR 820.198; Manufacture Medical Device |
| Location | EAST TAMAKI Auckland, NZ |
| New listings | 1 |
| Devices | Humidifier, Respiratory Gas, (Direct Patient Interface) |
| Product codes | BTT |
| Device classes | Class II |
| Medical specialties | Anesthesiology |
| Brand names | Optiflow Oxygen Kit |
| First new listing | 2026-09-01 |
| Latest new listing | 2026-09-01 |
| FDA registration number | 9611451 |
| Registration expires | 2027-12-31 |
| amount percentile | 50th of 2,709 (median 2, 0.5x median) |
| Peer records CSV (4 NZ records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
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CSV columns: Establishment · Role · New listings · Devices · Latest listing · official source URL
- Source agency: openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
- Record date: 2026-09-01
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
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LIVE PUBLIC DATA Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) · Last refreshed: Wed, 04 Nov 2026 21:52:36 GMT
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Peer benchmark and outreach value: Fisher & Paykel Healthcare, Ltd. and 4 NZ peers
- NZ DeviceEstablishmentPulse records like this one: 4
- Fisher & Paykel Healthcare, Ltd.'s amount: 50th percentile of 2,709 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every NZ peer: $800 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
60 / 100 Score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
What is the DeviceEstablishmentPulse record for Fisher & Paykel Healthcare, Ltd. in EAST TAMAKI Auckland?
Fisher & Paykel Healthcare, Ltd. (EAST TAMAKI Auckland, NZ), a manufacturer, added 1 FDA device listing on 2026-09-01.
How does Fisher & Paykel Healthcare, Ltd. compare to other DeviceEstablishmentPulse records?
Its amount of 1 sits in the upper half (50th percentile) of 2,709 records; the median is 2. It is 66 days old; check the official source for later updates before acting.
Fisher & Paykel Healthcare, Ltd. vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| Fisher & Paykel Healthcare, Ltd. | EAST TAMAKI Auckland, NZ | 1 | 50th | 2026-09-01 |
| Applied Medical Resources Corp. | Rsm, CA | 3 | 77th | 2026-10-23 |
| Tornier, Inc. | Bloomington, MN | 3 | 77th | 2026-10-21 |
| Treace Medical Concepts, Inc. | Ponte Vedra, FL | 3 | 77th | 2026-10-20 |
Related records
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- Tornier, Inc.
- Treace Medical Concepts, Inc.
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DeviceEstablishmentPulse: Manufacturer DeviceEstablishmentPulse: Foreign establishment
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From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.