Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Respire Medical with 5 device recalls and 3 510(k) clearances. The most recent is a 510(k) clearance dated May 31, 2022: Respire Clear.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| May 31, 2022 | Respire ClearK214096 · LRK | 510(k) clearances |
| Sep 1, 2017 | Respire Pink Series EF+ Oral Sleep Apnea Device.Class II · Potential for device breakage during use | Device recalls |
| Sep 1, 2017 | Respire Pink H/S Oral Sleep Apnea DeviceClass II · Potential for device breakage during use | Device recalls |
| Sep 1, 2017 | Respire Pink H/S Oral Sleep Apnea DeviceClass II · Potential for device breakage during use | Device recalls |
| Sep 1, 2017 | Respire Pink+ Hard/Soft Oral Sleep Apnea DeviceClass II · Potential for device breakage during use | Device recalls |
| Sep 1, 2017 | Respire Pink+ Hard Oral Sleep Apnea DeviceClass II · Potential for device breakage during use | Device recalls |
| Sep 9, 2013 | RESPIRE PINK SERIES - HERBSTK131138 · LRK | 510(k) clearances |
| Aug 23, 2011 | RESPIRE BLUE SERIESK111207 · LRK | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
