# K990871: Pillowpositive Cervical Pillow

- Pathway: 510(k) (Traditional)
- Applicant: Lifesleep Systems, Inc.
- Decided: Jun 10, 1999 after 86 days
- Product code: MYB (Pillow, Cervical (For Mild Sleep Apnea))
- Device class: 2
- Regulation: 21 CFR 872.5570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
8 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Dr. Jonathan A. Parker’s PM Positioner: named in the summary without a submission number
- (no number) Dr. Jonathan A. Parker’s Adjustable PM Positioner: named in the summary without a submission number
- (no number) LifeSleep PillowPositive for snoring: named in the summary without a submission number
- (no number) Ortho-Rest Company’s A-Just Right Pillow: named in the summary without a submission number

## Most influential descendants
- K052597: Breathex Omega Cpap Device, Model 322 (2005), 7 descendants of its own
- K100121: Model 300157 Cpap System (2010), 5 descendants of its own
- K132127: Transcend Auto (2013), 1 descendant of its own
- K121374: ZI Blower (2013), 1 descendant of its own
- K180388: Transcend 365 miniCPAP System (2018), 0 descendants of its own

## Indications for use
PillowPositive Cervical Pillow (“PillowPositive”) is indicated for the reduction of symptoms (apneas and hypopneas) associated with mild obstructive sleep apnea.

Source page: https://510kreport.com/device/K990871
Methodology: https://510kreport.com/methodology