Fisher & Paykel Healthcare, Inc. (other, Irvine, CA): 1 new FDA device listing, incl. humidifier, respiratory gas, (direct patient interface)
Fisher & Paykel Healthcare, Inc. (Irvine, California): 1 new FDA device listing, incl. humidifier, respiratory gas, (direct patient interface). Its amount of 1 is above the median of 1 (50th percentile). Dated 65 days ago, it serves as a historical benchmark. Score 50/100. As of 2026-10-28, 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 2,570 DeviceEstablishmentPulse records · 1.0x the median
Free preview: all 15 published fields of this record are shown below. Locked: 283 related CA DeviceEstablishmentPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Establishment | Fisher & Paykel Healthcare, Inc. |
| Owner / operator | Fisher & Paykel Healthcare Nz Ltd |
| Role | Other |
| Establishment types | Complaint File Establishment per 21 CFR 820.198 |
| Location | Irvine, CA, US |
| 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 | 2085602 |
| Registration expires | 2027-12-31 |
| amount percentile | 50th of 2,570 (median 1, 1.0x median) |
| Peer records CSV (284 CA records) | 🔒 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: 2026-10-28
- 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, 28 Oct 2026 20:51:27 GMT
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Peer benchmark and outreach value: Fisher & Paykel Healthcare, Inc. and 284 California peers
- California DeviceEstablishmentPulse records like this one: 284
- Fisher & Paykel Healthcare, Inc.'s amount: 50th percentile of 2,570 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every California peer: $56,800 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
50 / 100 Score
- Class II or III devices: QMS and regulatory demands.
- U.S. establishment.
What is the DeviceEstablishmentPulse record for Fisher & Paykel Healthcare, Inc. in Irvine, California?
Fisher & Paykel Healthcare, Inc. (Irvine, CA), a other, added 1 FDA device listing on 2026-09-01.
How does Fisher & Paykel Healthcare, Inc. compare to other California DeviceEstablishmentPulse records?
Its amount of 1 sits in the upper half (50th percentile) of 2,570 records; the median is 1. It is 65 days old; check the official source for later updates before acting.
Fisher & Paykel Healthcare, Inc. vs. top 2 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| Fisher & Paykel Healthcare, Inc. | Irvine, CA | 1 | 50th | 2026-09-01 |
| Integrity United Inc Dba Costcare | Anaheim, CA | 3 | 77th | 2026-09-08 |
| Karl Storz Endoscopy-America, Inc. | El Segundo, CA | 15 | 96th | 2026-09-28 |
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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.