Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
MYB · Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
98 daysmedian FDA review time
125 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K180608 | Lunoa System | Nightbalance BV | 2018-06-05 | 90 | 0 |
| K140190 | NIGHT SHIFT | Advanced Brain Monitoring, Inc. | 2014-05-29 | 125 | 0 |
| K100160 | ZZOMA POSITIONAL SLEEPER MODEL 001 | Sleep Specialists, LLC | 2010-05-11 | 111 | 0 |
| K040161 | SONA PILLOW | Sleep Devices, Inc. | 2004-04-30 | 98 | 0 |
| K023010 | SNIFF POSITION PILLOWS/POPITZ PILLOWS | Aeolus International Corporation | 2002-10-01 | 22 | 0 |
| K990871 | PILLOWPOSITIVE CERVICAL PILLOW | Lifesleep Systems, Inc. | 1999-06-10 | 86 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda