FDA product code MYB: Pillow, Cervical (For Mild Sleep Apnea)
MYB is the FDA product code for pillow, cervical (for mild sleep apnea). It is a Class II device, regulated under 21 CFR 872.5570 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 6 510(k) submissions under MYB, from 6 different applicants. The average 510(k) review took 89 days (median 94).
Classification
| Field | Value |
|---|---|
| Device name | Pillow, Cervical (For Mild Sleep Apnea) |
| Device class | Class II |
| Regulation | 21 CFR 872.5570 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Dental |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for MYB
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 90 |
Compare with all 510(k) review times · Search every MYB clearance
Top MYB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Nightbalance BV | 1 | 2018-06-05 |
| Advanced Brain Monitoring, Inc. | 1 | 2014-05-29 |
| Sleep Specialists, LLC | 1 | 2010-05-11 |
| Sleep Devices, Inc. | 1 | 2004-04-30 |
| Aeolus International Corporation | 1 | 2002-10-01 |
1 more applicants have MYB clearances. See the full list in Caduvo.
Most recent MYB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K180608 | Nightbalance BV | Lunoa System | 2018-06-05 | 90 |
| K140190 | Advanced Brain Monitoring, Inc. | NIGHT SHIFT | 2014-05-29 | 125 |
| K100160 | Sleep Specialists, LLC | ZZOMA POSITIONAL SLEEPER MODEL 001 | 2010-05-11 | 111 |
| K040161 | Sleep Devices, Inc. | SONA PILLOW | 2004-04-30 | 98 |
| K023010 | Aeolus International Corporation | SNIFF POSITION PILLOWS/POPITZ PILLOWS | 2002-10-01 | 22 |
Recalls for MYB devices
openFDA lists no recalls for product code MYB.
Frequently asked questions
What is FDA product code MYB?
MYB is the FDA product code for pillow, cervical (for mild sleep apnea). It is a Class II device, regulated under 21 CFR 872.5570 and reviewed by the Ear, Nose and Throat panel.
What device class is MYB?
Class II, regulation 21 CFR 872.5570. Typical premarket route: 510(k).
How long does a 510(k) take for product code MYB?
Across 6 cleared submissions the average was 89 days from receipt to decision (median 94).
Which companies have the most MYB clearances?
Nightbalance BV (1); Advanced Brain Monitoring, Inc. (1); Sleep Specialists, LLC (1); Sleep Devices, Inc. (1); Aeolus International Corporation (1).
Next steps
- Run an FDA pathway report with predicate devices for product code MYB
- Run a recall and safety report across every MYB manufacturer
- Watch product code MYB 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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