Product Code: MYB FDA class 2 21 CFR 872.5570

Pillow, Cervical (For Mild Sleep Apnea)

Dental

The Cervical Pillow for Mild Sleep Apnea is a specially designed orthopedic pillow intended to position the head and neck in a manner that helps maintain airway patency during sleep, thereby reducing the frequency and severity of mild obstructive sleep apnea episodes. Classified as FDA Class 2, it requires 510(k) premarket clearance under regulation 872.5570 (Dental specialty, reviewed by the Ear, Nose, and Throat panel). This device is eligible for third-party 510(k) review.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

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Basic Information

Product Code: MYB
Device Class: FDA class 2
Regulation Number: 872.5570
Medical Specialty: Dental
Review Panel: EN
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 6 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K180608	Lunoa System	Jun 05, 2018	Substantially Equivalent	Nightbalance BV
K140190	NIGHT SHIFT	May 29, 2014	Substantially Equivalent	Advanced Brain Monitoring, Inc.
K100160	ZZOMA POSITIONAL SLEEPER MODEL 001	May 11, 2010	Substantially Equivalent	Sleep Specialists, LLC
K040161	SONA PILLOW	Apr 30, 2004	Substantially Equivalent	Sleep Devices, Inc.
K023010	SNIFF POSITION PILLOWS/POPITZ PILLOWS	Oct 01, 2002	Substantially Equivalent	Aeolus International Corporation
K990871	PILLOWPOSITIVE CERVICAL PILLOW	Jun 10, 1999	Substantially Equivalent	Lifesleep Systems, Inc.