FDA product code SGR: Noninvasive Positive Airway Pressure System, Facility Use
SGR is the FDA product code for noninvasive positive airway pressure system, facility use. It is a Class II device, regulated under 21 CFR 868.5895 and reviewed by the Anesthesiology panel. FDA has cleared 2 510(k) submissions under SGR, 2 in the last five years, from 2 different applicants. The average 510(k) review took 263 days (median 263); 263 days on average over the last three years.
Definition
To mechanically assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas through noninvasive continuous positive airway pressure.
Classification
| Field | Value |
|---|---|
| Device name | Noninvasive Positive Airway Pressure System, Facility Use |
| Device class | Class II |
| Regulation | 21 CFR 868.5895 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) |
510(k) clearances per year for SGR
| Year | Clearances | Avg. review days |
|---|---|---|
| 2025 | 1 | 260 |
| 2026 | 1 | 266 |
Compare with all 510(k) review times · Search every SGR clearance
Top SGR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Innaccel Technologies Private Limited | 1 | 2026-01-06 |
| Fisher & Paykel Healthcare, Ltd. | 1 | 2025-11-19 |
Most recent SGR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K251165 | Innaccel Technologies Private Limited | Saans (F4-01-00-000-000) | 2026-01-06 | 266 |
| K250651 | Fisher & Paykel Healthcare, Ltd. | OptiPAP Junior Flexi Tube US (OPTIPAPFUS); OptiPAP Junior Nasal Prongs XXS (OPTIPAPPXXS); OptiPAP Junior Nasal Prongs XS (OPTIPAPPXS); OptiPAP Junior Nasal Prongs S (OPTIPAPPS); OptiPAP Junior Nasal Prongs M (OPTIPAPPM); OptiPAP Junior Nasal Prongs L (OPTIPAPPL); OptiPAP Junior Nasal Prongs XL (OPTIPAPPXL); OptiPAP Junior Nasal Mask XXS (OPTIPAPMXXS); OptiPAP Junior Nasal Mask XS (OPTIPAPMXS); OptiPAP Junior Nasal Mask S (OPTIPAPMS); OptiPAP Junior Nasal Mask M (OPTIPAPMM); OptiPAP Jun | 2025-11-19 | 260 |
Recalls for SGR devices
openFDA lists no recalls for product code SGR.
Frequently asked questions
What is FDA product code SGR?
SGR is the FDA product code for noninvasive positive airway pressure system, facility use. It is a Class II device, regulated under 21 CFR 868.5895 and reviewed by the Anesthesiology panel.
What device class is SGR?
Class II, regulation 21 CFR 868.5895. Typical premarket route: 510(k).
How long does a 510(k) take for product code SGR?
Across 2 cleared submissions the average was 263 days from receipt to decision (median 263).
Which companies have the most SGR clearances?
Innaccel Technologies Private Limited (1); Fisher & Paykel Healthcare, Ltd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code SGR
- Run a recall and safety report across every SGR manufacturer
- Watch product code SGR for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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