510(k) Report

510(k) · Cleared

Cleared

Sona Pillow

K040161510(k) TraditionalCleared Apr 30, 200498-day reviewClass II21 CFR 872.5570

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Sleep Devices, Inc. · MYB Pillow, Cervical (For Mild Sleep Apnea)

Cleared on Apr 30, 2004 after a 98-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it.

Decided
Apr 30, 2004
Review
98 days
Class
Class II
Product code
MYB
Recalls
None
Predicates
0

3 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2010: 1 descendant cleared2014: 1 descendant cleared2018: 1 descendant cleared200020052010201520202025
  1. This deviceK040161 Sona PillowSleep Devices, Inc. · 2004
  2. Descendant · cites it directly · 2 of its ownK100160 Zzoma Positional Sleeper Model 001Sleep Specialists, LLC · 2010
  3. Descendant · 2 generations on · 1 of its ownK140190 Night ShiftAdvanced Brain Monitoring, Inc. · 2014
  4. Descendant · 3 generations on · 0 of its ownK180608 Lunoa SystemNightbalance BV · 2018

Most influential descendants

Showing 3 of 3 · See all
  • K100160Zzoma Positional Sleeper Model 001Sleep Specialists, LLC · 2010 · cites it directly2descendants
  • K140190Night ShiftAdvanced Brain Monitoring, Inc. · 2014 · 2 generations on1descendant
  • K180608Lunoa SystemNightbalance BV · 2018 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K040161Sona PillowSleep Devices, Inc.2004—
+1K100160Zzoma Positional Sleeper Model 001Sleep Specialists, LLC2010—
+2K140190Night ShiftAdvanced Brain Monitoring, Inc.2014—
+3K180608Lunoa SystemNightbalance BV2018—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201410
201810
FIG. 1 — Lineage of K040161, 2004–2018Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in MYB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (3)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K100160Zzoma Positional Sleeper Model 001Sleep Specialists, LLC20102

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K100160 (Sleep Specialists, LLC, 2010) has gone furthest, with 2 descendants of its own.

How does its category compare?

All MYB devices

MYB Pillow, Cervical (For Mild Sleep Apnea): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MYB

1in 2018

2010: 12014: 12018: 1
2007high 1 (2010) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MYB

Too few MYB 510(k)s in any year since 2007 to give a median.

Recalls per year · MYB

No recall names MYB since 2007.

Adverse event reports per year · MYB

1in 2025

2007: 22025: 1
2007high 2 (2007) · low 0 (2008)2025

MAUDE reports naming product code MYB, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—02
20080—00
20090—00
20101—00
20110—00
20120—00
20130—00
20141—00
20150—00
20160—00
20170—00
20181—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—01
20260—0—

What is it indicated for?

MAY STOP OR DECREASE SNORING

MAY BE UUSED TO TREAT MILD OBSTRUCTIVE SLLEEP APNEA

MAY IMPROVE TTIT: QUALITY OF SLEEP

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

Recent decisions in MYB

The MYB category page

  • K180608Lunoa SystemNightbalance BV · 2018
  • K140190Night ShiftAdvanced Brain Monitoring, Inc. · 2014
  • K100160Zzoma Positional Sleeper Model 001Sleep Specialists, LLC · 2010
  • K023010Sniff Position Pillows/Popitz PillowsAeolus International Corporation · 2002
  • K990871Pillowpositive Cervical PillowLifesleep Systems, Inc. · 1999

https://510kreport.com/device/K040161 · printed Nov 5, 2026

Cite this page

510(k) Report. “K040161: Sona Pillow.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K040161

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026