ClearanceBrief
Company ยท US

Respire Medical

FDA 510(k) clearances and medical device recalls filed under this name, 2011 to 2022. Name variants (Inc, Corp, punctuation) are merged.

3510(k) clearances (0 in 12 months)
5recalls (0 in 12 months)
3recalls that name a 510(k)

Product codes

CodeDeviceRecords
LRKDevice, Anti-Snoring8

Latest 510(k) clearances

Decided510(k)Device and applicantCode
May 31, 2022K214096Respire Clear
Respire Medical, LLC
LRK
Sep 9, 2013K131138RESPIRE PINK SERIES - HERBST
Respire Medical
LRK
Aug 23, 2011K111207RESPIRE BLUE SERIES
Respire Medical
LRK

Latest recalls

DateFirm and productCodeLinked 510(k)
May 29, 2018Respire Medical
Respire Pink H/S Oral Sleep Apnea Device
Terminated		 LRKNone listed
May 29, 2018Respire Medical
Respire Pink H/S Oral Sleep Apnea Device
Terminated		 LRKNone listed
May 29, 2018Respire Medical
Respire Pink+ Hard Oral Sleep Apnea Device
Terminated		 LRKK150572
May 29, 2018Respire Medical
Respire Pink+ Hard/Soft Oral Sleep Apnea Device
Terminated		 LRKK150572
May 29, 2018Respire Medical
Respire Pink Series EF+ Oral Sleep Apnea Device.
Terminated		 LRKK150572
Get alerts for these product codes