510(k) Report

FDA applicant

Respire Medical Holding

Brooklyn, NY3 decisions2015–20173 recalls

FDA records 3 decisions for Respire Medical Holding (Brooklyn, NY) from 2015 to 2017: 3 510(k) clearances. All are in product code LRK (Device, Anti-Snoring). Its devices cite 5 predicates, 1 of them its own earlier devices. 3 recalls are linked to its devices.

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

FIG. A — Illustration, dental panel, where it files most

How often FDA has decided Respire Medical Holding’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2015: 22017: 1
2015high 2 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

3in 2017

2017: 3
2015high 3 (2017) · low 0 (2015)2026

Class I Class II/III not classified

FIG. 1 — Respire Medical Holding by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LRKDevice, Anti-Snoring3decisions

Whose devices does it build on?

Its devices cite 5 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K150572Respire Pink Series-Herbst-EFRespire Medical Holding · 20153cite it
  • K170692Respire Pink Series with DentiTracRespire Medical Holding · 20172cite it

What has FDA decided for it lately?

  • K170692Respire Pink Series with DentiTracRespire Medical Holding · 2017
  • K152292Respire Blue Series-EFRespire Medical Holding · 2015
  • K150572Respire Pink Series-Herbst-EFRespire Medical Holding · 20153 recalls

All 3 as Respire Medical Holding →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K150572Respire Pink Series EF+ Oral Sleep Apnea Device.Sep 1, 2017Class II
  • K150572Respire Pink+ Hard/Soft Oral Sleep Apnea DeviceSep 1, 2017Class II
  • K150572Respire Pink+ Hard Oral Sleep Apnea DeviceSep 1, 2017Class II

Other applicant names beginning “Respire”

FDA records each applicant name separately; these may or may not be the same firm.

Respire Medical 3Respire Medical Holdings 1