MYB
6 FDA 510(k) clearances · Product code
98 daysmedian time to decision
125 days90th percentile
6clearances measured
FDA profile
- Official device name
- Pillow, Cervical (For Mild Sleep Apnea)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 872.5570
- Medical specialty
- Dental
- Flags
- Third-party review eligible
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Both buttons carry the same predicate table: the CSV downloads for your worksheet, the report is a shareable page for clients. Exports: 3 free/month with an account · reports & watching free.
Building a predicate table? Click + Add on candidates below (up to 8), then compare and export from your Builder.
| Record | Firm | Date | Builder |
|---|---|---|---|
| Lunoa System (K180608) | Nightbalance BV | 2018-06-05 | + Add |
| NIGHT SHIFT (K140190) | Advanced Brain Monitoring, Inc. | 2014-05-29 | + Add |
| ZZOMA POSITIONAL SLEEPER MODEL 001 (K100160) | Sleep Specialists, LLC | 2010-05-11 | + Add |
| SONA PILLOW (K040161) | Sleep Devices, Inc. | 2004-04-30 | + Add |
| SNIFF POSITION PILLOWS/POPITZ PILLOWS (K023010) | Aeolus International Corporation | 2002-10-01 | + Add |
| PILLOWPOSITIVE CERVICAL PILLOW (K990871) | Lifesleep Systems, Inc. | 1999-06-10 | + Add |
Track MYB automatically
Every clearance here is in the API, with alerts when new ones post.