Respire Medical

Woodland Hills, CA, US

Respire Medical appears in FDA device records in Woodland Hills, CA. FDA records list 3 510(k) clearances between 2011-08-23 and 2022-05-31, no PMA records and no registered establishments. As of 2026-09-10, FDA records show 5 recalls for this company.

510(k) clearances: 3
PMA records: 0
Recall records: 5
Registered establishments: 0

510(k) clearance history

FDA records hold 3 510(k) clearances for Respire Medical between 2011 and 2022. The busiest year on record is 2011, with 1. The most recent is 2022, with 1.

Clearances by year, as a table

510(k) clearance decisions for Respire Medical, by decision year
Year	Clearances
2011	1
2013	1
2022	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K214096	Respire Clear	LRK	Substantially Equivalent	2022-05-31
K131138	RESPIRE PINK SERIES - HERBST	LRK	Substantially Equivalent	2013-09-09
K111207	RESPIRE BLUE SERIES	LRK	Substantially Equivalent	2011-08-23

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

LRKDevice, Anti-Snoring

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-1951-2018	Respire Pink H/S Oral Sleep Apnea Device	Potential for device breakage during use	Class II	2017-09-01	Terminated
Z-1950-2018	Respire Pink H/S Oral Sleep Apnea Device	Potential for device breakage during use	Class II	2017-09-01	Terminated
Z-1949-2018	Respire Pink+ Hard Oral Sleep Apnea Device	Potential for device breakage during use	Class II	2017-09-01	Terminated
Z-1948-2018	Respire Pink+ Hard/Soft Oral Sleep Apnea Device	Potential for device breakage during use	Class II	2017-09-01	Terminated
Z-1947-2018	Respire Pink Series EF+ Oral Sleep Apnea Device.	Potential for device breakage during use	Class II	2017-09-01	Terminated

Verification record

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain