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Sniff Position Pillows/Popitz Pillows

by Aeolus International Corporation

510(k) K023010

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Abbreviated NumberK023010 Date1 Oct 2002ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
MYB
Device Class
Class II
Regulation
21 CFR Part 872.5570
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Sniff Position Pillows/Popitz Pillows are intraoral devices designed to position patients in the sniff position, which is optimal for intubation or mask ventilation. These pillows provide support and cradle the patient's head, offering a reliable alternative to folded towels, blankets, or other positioning aids. The device is classified as a cervical pillow for mild sleep apnea and is intended to help maintain proper head alignment during medical procedures.

The Sniff Position Pillows are supplied by Aeolus International Corporation and are authorized under FDA 510(k) clearance with product code MYB. They are available in various sizes as indicated by the multiple registration numbers provided. The device is regulated under number 872.5570 and is intended for dental and medical specialties. No information regarding sterility, single-use status, or MRI safety is provided in the device data.

Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What are Sniff Position Pillows used for?

    The Sniff Position Pillows are intraoral devices designed to position patients in the sniff position, which is optimal for intubation or mask ventilation. They provide support and cradle the patient's head, offering a reliable alternative to folded towels or other positioning aids.

  • How are the Sniff Position Pillows supplied?

    The Sniff Position Pillows are supplied by Aeolus International Corporation and are available in various sizes as indicated by the multiple registration numbers provided. The device is classified as a cervical pillow for mild sleep apnea.

  • What is the regulatory status of the Sniff Position Pillows?

    The Sniff Position Pillows are authorized under FDA 510(k) clearance with product code MYB. They are regulated under number 872.5570 and are intended for dental and medical specialties. No information regarding sterility, single-use status, or MRI safety is provided in the device data.

  • How do Sniff Position Pillows help during medical procedures?

    These pillows help maintain proper head alignment during medical procedures by positioning patients in the sniff position. This positioning is particularly beneficial for intubation or mask ventilation, ensuring optimal airway management during dental and medical specialties.