Panels › Anesthesiology › Product code SGR · Class 2
Noninvasive Positive Airway Pressure System, Facility Use
Regulation 868.5895
2510(k)s in 12 months (2 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in SGR
| Company | 510(k)s | Recalls |
|---|---|---|
| Fisher & Paykel Healthcare, Ltd. | 1 | 0 |
| Innaccel Technologies Private Limited | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 6, 2026 | K251165 | Saans (F4-01-00-000-000) Innaccel Technologies Private Limited, IN | SGR |
| Nov 19, 2025 | K250651 | OptiPAP Junior Flexi Tube US (OPTIPAPFUS); OptiPAP Junior Nasal Prongs XXS (OPTIPAPPXXS); OptiPAP Junior Nasal Prongs XS Fisher & Paykel Healthcare, Ltd., NZ | SGR |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.