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Respire Pink Series Herbst

by Respire Medical

510(k) K131138

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK131138 Date9 Sep 2013ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 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  • Withdrawn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
LRK
Device Class
Class II
Regulation
21 CFR Part 872.5570
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

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

The Respire Pink Series Herbst is a custom-fitted, two-piece mandibular advancement splint constructed from acrylic. It is designed to treat snoring and mild to moderate obstructive sleep apnea by holding the mandible in a forward position to maintain an open airway during sleep.

This device features telescopic Herbst hardware on the buccal aspect, which allows for lateral and protrusive jaw movement. It is an FDA 510(k) authorized device.

Other devices from Respire Medical

Questions

AI-generated answers, 21 Sep 2026

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

  • What is the primary purpose of the Respire Pink Series Herbst?

    This device is designed to treat snoring and mild to moderate obstructive sleep apnea. It functions by holding the mandible in a forward position during sleep, which helps to maintain an open airway.

  • How is the device constructed and fitted?

    The Respire Pink Series Herbst is a custom-fitted, two-piece mandibular advancement splint constructed from acrylic. Because it is custom-fitted, it is designed to match the specific anatomy of the patient.

  • Does the device restrict jaw movement?

    No, the device features telescopic Herbst hardware on the buccal aspect. This specific hardware design allows for both lateral and protrusive jaw movement while the device is in use.

  • What is the regulatory status of this device?

    The Respire Pink Series Herbst is an FDA 510(k) authorized device. This indicates that the manufacturer has successfully completed the FDA 510(k) submission process for this product.