Data / Medical devices / Noninvasive Positive Airway Pressure System, Facility Use
Noninvasive Positive Airway Pressure System, Facility Use (SGR): 4 FDA-registered makers in 3 countries
4 establishments in 3 countries are registered with the FDA to make Noninvasive Positive Airway Pressure System, Facility Use (product code SGR, Class 2, 21 CFR 868.5895). 2 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 2 510(k) clearances under this code, the latest on January 6, 2026, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- SGR
- Device class
- 2
- Regulation
- 868.5895
- Medical specialty
- Anesthesiology
Makers by country
| Country | Makers |
|---|---|
| Mexico | 2 |
| New Zealand | 1 |
| India | 1 |
Makers of Noninvasive Positive Airway Pressure System, Facility Use
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Fisher & Paykel Healthcare, Ltd. | EAST TAMAKI Auckland, New Zealand | Complaint file establishment, Manufacturer | 1 | November 19, 2025 | 0 | 0 | 0 | api.fda.gov |
| Innaccel Technologies Private Limited | BANGALORE Karnataka, India | Manufacturer | 1 | January 6, 2026 | 0 | 0 | 0 | api.fda.gov |
| Fisher & Paykel Healthcare S.a.de C.V. | Tijuana, Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fisher & Paykel Healthcare S.A.de C.V. | Tijuana Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated January 6, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.