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510(k) Data Aggregation
K Number
K214096Device Name
Respire Clear
Manufacturer
Respire Medical, LLC
Date Cleared
2022-05-31
(154 days)
Product Code
LRK, KMY, LQZ
Regulation Number
872.5570Why did this record match?
Applicant Name (Manufacturer) :
Respire Medical, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Respire Clear is indicated to treat mild to moderate Obstructive Sleep Apnea (OSA) in patients, 18 years of age or older.
Device Description
The Respire Clear is an oral appliance used in the treatment of mild to moderate obstructive sleep apnea. This device helps move a patient's jaw forward, thus opening their airways, and allowing them to breathe more easily throughout the night. The Respire Clear is made out of dental industry standard 3D printed resins & metals, and is custom designed to fit each patients' unique oral anatomy.
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K Number
K192127Device Name
Respire Pink AT (Hard, Hard/Soft, EF)
Manufacturer
Respire Medical Holdings
Date Cleared
2020-02-05
(183 days)
Product Code
LRK
Regulation Number
872.5570Why did this record match?
Applicant Name (Manufacturer) :
Respire Medical Holdings
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Our devices are indicated to treat mild to moderate Obstructive Sleep Apnea (OSA) in patients, 18 years of age or older.
Device Description
The Respire Pink AT (Hard, Hard/Soft, EF) is an oral appliance used in the treatment of mild to moderate obstructive sleep apnea. This device helps move a patient's jaw forward, thus opening their airways, and allowing them to breathe more easily throughout the night. The Respire Pink AT (Hard, Hard/Soft, EF) is made out of dental industry standard acrylic resins & metals, and is custom designed to comfortably fit each patients' unique oral anatomy.
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K Number
K170692Device Name
Respire Pink Series with DentiTrac
Manufacturer
Respire Medical Holding
Date Cleared
2017-05-26
(80 days)
Product Code
LRK, PLC
Regulation Number
872.5570Why did this record match?
Applicant Name (Manufacturer) :
Respire Medical Holding
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Respire Pink Series intraoral appliances are intended to treat snoring and mild to moderate Obstructive Sleep Apnea (OSA) in adult patients 18 years of age or older.
Optionally, the DentiTrac® micro-recorder may be incorporated into a Respire Pink Series device. The micro-recorder is intended to measure patient compliance to oral appliance therapy in combination with the DentiTrac® system.
Device Description
The Respire Pink Series with DentiTrac® refers to two devices: Respire Pink Series-Herbst and the Respire Pink Series-Herbst-EF, herein referred to collectively as Respire Pink Series. These devices function as mandibular advancement splints which hold the jaw in a forward position. The forward jaw placement moves the tongue and pharyngeal tissue into a position to help maintain an open airway, which allows the passage of more air per breath and helps in the treatment of snoring and mild to moderate Obstructive Sleep Apnea (OSA). Respire Pink Series appliances are customizable devices which are produced according to the individual patient anatomy and prescription.
The Respire Pink Series-Herbst consists of full hard acrylic upper and lower fitting surfaces, and the Respire Pink Series-Herbst-EF consists of hard acrylic fitting side plates and chrome (BEGO Wironit®) upper palatal and lower lingual plates. The Herbst hardware on the side of the device allows for forward and lateral jaw movement while restricting backward jaw movement, and allows the patient to open and close the mouth. The Herbst hardware contains an expansion screw for mandibular position adjustment, and is attached to the appliance using medical grade stainless steel fixing elements and screws.
This submission is to provide clinicians the option to incorporate a Braebon DentiTrac® micro-recorder into a Respire Pink Series device. The micro-recorder is encapsulated in Loctite epoxy and fully encased into the device acrylic, and is not patient contacting. The micro-recorder is utilized to track patient compliance to prescribed oral appliance therapy by collecting data for wear-time through oral temperature, movement tracking, and head position. The data can be uploaded to a cloud-based web application using the DeniTrac® system which allows clinicians to review the patient data. The inclusion of the microrecorder provides additional treatment information to clinicians without effecting the operating principles of the Respire Pink Series devices.
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K Number
K152292Device Name
Respire Blue Series-EF
Manufacturer
Respire Medical Holding
Date Cleared
2015-12-07
(116 days)
Product Code
LRK
Regulation Number
872.5570Why did this record match?
Applicant Name (Manufacturer) :
Respire Medical Holding
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Respire Blue Scries - EF is indicated to treat mild to moderate OSA (Obstructive Sleep Apnea)
Device Description
The Respire Blue Series – EF (Endurance Frameworks) – is available with a hard device fitting surface. The hard surface consists of Acrylic (side plates / trays) and chrome - Wironit material (upper / Palatal and lower / Lingual plates / trays). Refer to Figure 1 Representative Drawing. The device is retained with ball and clasps which are used to hold elastic bands which guide the jaw to the desired position. In addition there are expansion screws inside the Acrylic side plates / trays that allows for device expansion based on patient needs.
The upper and lower components are connected by an adjustable hinge, thus the patient can open and close the mouth while wearing the appliances
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K Number
K150572Device Name
Respire Pink Series-Herbst-EF
Manufacturer
Respire Medical Holding
Date Cleared
2015-08-27
(174 days)
Product Code
LRK
Regulation Number
872.5570Why did this record match?
Applicant Name (Manufacturer) :
Respire Medical Holding
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Respire Pink Series - Herbst - EF is indicated to treat mild to moderate OSA.
Device Description
The Respire Pink Series - Herbst - EF (Endurance Frameworks) - is available with a hard device fitting surface. The hard surface consists of Acrylic (side plates) and chrome - Wironit material ( upper / Palatal and lower / Lingual plates). Refer to Figure 1 Representative Drawing. The device is retained with ball and clasps which allows the device to be tightened if it becomes loose. The device is a mandibular advancement splint that holds the jaw in a forward position to help keep the tongue and supporting tissues in a position to help maintain an open airway, which helps in the treatment of snoring and mild to moderate obstructive sleep apnea. The Herbst hardware on the side of the device allows the patient to move forward and left and right, but not backwards. These movements give the patient some freedom to move which is important for their comfort and overall success of the device. The upper and lower components are connected by an adjustable hinge, thus patient can open and close while wearing the appliances.
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K Number
K131138Device Name
RESPIRE PINK SERIES - HERBST
Manufacturer
RESPIRE MEDICAL
Date Cleared
2013-09-09
(139 days)
Product Code
LRK
Regulation Number
872.5570Why did this record match?
Applicant Name (Manufacturer) :
RESPIRE MEDICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Respire Pink Series - Herbst is indicated to treat mild to moderate OSA.
Device Description
Respire Pink Series - Herbst is a customized device for each patient which consists of two dental plates, upper and lower, made of Acrylic.
The Respire Pink Series – Herbst is a mandibular advancement splint that holds the jaw in a forward position to help keep the tongue and supporting tissues in a position to help maintain an open airway, which in turn helps in the treatment of snoring and mild to moderate obstructive sleep apnea.
The Herbst hardware on the side of the devices allow the patient to move forward and left and right, but not backwards. These movements give the patient some freedom to move which is important for their comfort and overall success of the device.
The upper and lower components are connected by an adjustable hinge, thus patient can open and close while wearing the appliances.
Respire Pink Series - Herbst are offered in two options: {1) Hard/Soft which has a dual laminate layer that provides a soft layer on the tooth surface (2) Hard devices which are all acrylic and retained with ball clasps, this allows the device to be tightened if it it becomes loose.
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K Number
K111207Device Name
RESPIRE BLUE SERIES
Manufacturer
RESPIRE MEDICAL
Date Cleared
2011-08-23
(116 days)
Product Code
LRK
Regulation Number
872.5570Why did this record match?
Applicant Name (Manufacturer) :
RESPIRE MEDICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Respire Blue Series is indicated to treat mild to moderate OSA.
Device Description
Respire Blue Series is a patented, custom made device for each patient which consists of two dental plates, upper and lower, made of Acrylic. The attachment is at a 65 degree angle to enable movement of the appliances, thus patient can open and close while wearing the appliances. The appliance is open in the front to add comfort by allowing the patient to inhale and exhale more air per breath. Respire Blue Series are offered in two options: (1) Hard/Soft which has a dual laminate layer that provides a soft layer on the tooth surface (2) Hard devices which are all acrylic and retained with ball clasps, this allows the device to be tightened if it becomes loose.
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