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Found 80 results
510(k) Data Aggregation
K Number
K251450Device Name
Baby Nasal Aspirator (BN002); Baby Nasal Aspirator (BN006); Baby Nasal Aspirator (BN007); Baby Nasal Aspirator (BN008); Baby Nasal Aspirator (BN009)
Manufacturer
Shenzhen Desida Technology Co., Ltd.
Date Cleared
2025-06-06
(28 days)
Product Code
BTA
Regulation Number
878.4780Why did this record match?
Product Code :
BTA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Baby Nasal Aspirator is intended for intermittent removal of nasal secretions and mucus from children (age 2-12 years old). This device is used in a home environment.
Device Description
Not Found
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K Number
K244033Device Name
Electric Nasal Aspirator (NASA601,NASA602,NASA603,NASA605,NASA606,NASA608,NASA610)
Manufacturer
Shenzhen Desida Technology Co., Ltd.
Date Cleared
2025-05-16
(137 days)
Product Code
BTA
Regulation Number
878.4780Why did this record match?
Product Code :
BTA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Electric Nasal Aspirator is intended for intermittent removal of nasal secretions and mucus from children (age 2~12 years old). This device is used in a home environment.
Device Description
Electric Nasal Aspirator consists of silicone nozzle which has three models (conical nozzle, flat nozzle, angled nozzle), collection cup, air tube, tweezers, charging cable-USB and aspirator body. The Electric Nasal Aspirator is a portable device which is intended for suction of nasal passages in children 2-12 years of age. The motor pump provides a negative pressure which removes nasal secretions. The motor pump operates on a rechargeable battery. The rechargeable battery can be charged from the external power adapter (not included in this device) through the provided charging line.
The user interface consists of buttons and LED display, and the user can control the vacuum pressure through the button. Three different shapes of silicone nasal tips are provided to enable easier and more effective removal of the nasal mucus.
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K Number
K251101Device Name
AIRO Suction Unit (AIRO-01)
Manufacturer
CRO, LLC
Date Cleared
2025-04-26
(15 days)
Product Code
BTA
Regulation Number
878.4780Why did this record match?
Product Code :
BTA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AIRO Suction Unit, Model AIRO-01, is a portable, battery-powered medical suction device intended for use in emergency airway management procedures by professional medical providers. It is intended for intermittent operation to remove secretions, such as blood or vomit, during airway management procedures and other procedures for which an intermittent suction medical device may be applicable. The device is indicated for the suctioning of adult patients.
Device Description
The AIRO Suction Unit, Model AIRO-01, is a compact, handheld, portable battery-powered medical suction device intended for use in emergency airway management procedures by professional medical providers such as emergency medical technicians, paramedics, and hospital personnel. The device is not intended for contact with patient tissue during procedures. It is intended for intermittent operation to remove secretions, such as blood or vomit, during airway management procedures and other procedures for which an intermittent suction medical device may be applicable. The device is indicated for the suctioning of adult patients.
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K Number
K250697Device Name
Electric Nasal Aspirator (BC026, BC025, BC023)
Manufacturer
Shenzhen Kingboom Technology Co., Ltd
Date Cleared
2025-04-23
(47 days)
Product Code
BTA
Regulation Number
878.4780Why did this record match?
Product Code :
BTA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Electric Nasal Aspirator is intended for intermittent removal of nasal secretions and mucus from children (age 2-12 years old). This device is used in a home environment.
Device Description
Electric nasal aspirator (model: BC026, BC025 and BC023) consists of main unit, and suction portion working together as one unit. The Electric nasal aspirator is a portable device which is intended for suction of nasal passages in children 2-12 years of age. The motor pump provides a negative pressure which removes nasal secretions. The motor pump operates on a rechargeable battery. The rechargeable battery can be charged from the external power adapter (not included in this device) through the provided charging line. The user interface consists of buttons and LED display, and the user can control the vacuum pressure through the button.
The differences between BC026, BC025, and BC023 are as follows:
1) BC026 has 5 suction levels, while BC023 and BC025 have 3 suction levels.
2) BC026 and BC023 have "Light" function for distracting and pacifying the child. BC025 does not have this function.
3) BC026 and BC023 can pause suction during the suction process. BC025 does not have this feature.
4) BC026 and BC023 have 4 buttons, BC025 has 2 buttons.
5) In addition, BC026, BC025, and BC023 have different Display, Size, Weight, and Appearance.
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K Number
K241799Device Name
ATMOS C 051 Thorax (317.0200.0); Secretion canister 800ml (317.1300.0); Hose system (312.1177.0); Hose system with connector small (312.1206.0); Hose system with connector medium (312.1207.0); Hose system with connector large (312.1208.0); Hose system with Y-connector medium (312.1209.0); Hose system with Y-connector large (312.1210.0); Universal bracket for ATMOS C 051 Thorax (316.0200.0); Bracket for ATMOS C 051 Thorax - Standard rail (317.1160.0); Charger Storage for bracket ATMOS C
Manufacturer
ATMOS MedizinTechnik GmbH & Co. KG
Date Cleared
2025-03-07
(259 days)
Product Code
BTA
Regulation Number
878.4780Why did this record match?
Product Code :
BTA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ATMOS C 051 Thorax is indicated for aspiration and removal of surgical fluids, tissue, gases, bodily fluids, or infectious material from a patient's respiratory system after surgery. The general indication of the ATMOS C 051 Thorax is thoracic drainage.
Device Description
The ATMOS C 051 Thorax (317.0200.0) drainage system is a device for mobile, digital thoracic drainage. It is portable, mains-independent and has an electronic monitoring system with optical and acoustic display. The device takes medical effect as a system in combination with a secretion canister and a hose system. The system creates the (natural) vacuum in the pleural cavity by draining off air and secretion. The ATMOS C 051 Thorax is equipped with a rechargeable battery. A charging unit which is located within the suction device guarantees the secure charging of the battery. The hose system is rinsed with air at regular intervals to prevent the collection of debris in the hose. Bacterial and viral filters in the secretion canister and measuring hose prevent contaminated secretions from entering the device. The device is equipped with a disposable strap and a carrying handle. These enable mobility. A universal bracket or the standard rail bracket can be ordered separately as accessories. The ATMOS C 051 Thorax is a reusable device delivered in non-sterile state. The secretion canister and hose systems are single-use devices and delivered sterile. All other accessories subject to this submission are reusable and delivered non-sterile.
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K Number
K243138Device Name
Geon (S2) Nasal Aspirator
Manufacturer
Geon Corporation
Date Cleared
2025-02-04
(127 days)
Product Code
BTA
Regulation Number
878.4780Why did this record match?
Product Code :
BTA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Geon (S2) Nasal Aspirator is a hand-held, non-invasive, electronic medical device that provides negative pressure to remove nasal secretions and mucus from children (age 2-12 years old) at home environment.
Device Description
Geon Nasal Aspirator, model S2, is a hand-held, non-invasive, electronic medical device that provides negative pressure to remove nasal secretions and mucus from children (age 2-12 years old). Geon (S2) Nasal Aspirator is intended for over-the-counter (OTC) use at home environment. The main principle of operation is to utilize a pump to generate negative pressure in the suction system, which allows nasal secretions to flow into the device container.
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K Number
K241852Device Name
Nasal Aspirator (NS 13)
Manufacturer
AViTA Corporation
Date Cleared
2024-12-31
(187 days)
Product Code
BTA, KMA
Regulation Number
878.4780Why did this record match?
Product Code :
BTA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is designed for using suction to remove nasal secretion and mucus in Children (age 2~12 years old) at home environment.
The additional spray/irrigation function helps moisten and loosen/soften nasal secretions in Children (over 3 years old), making them easier to aspirate.
Device Description
This AViTA nasal aspirator (Model NS13) consists of a pump that can generate negative pressure suction, a silicone tip for contacting the nostrils, a collecting nasal mucus, a sprayer head module for moistening the nasal cavity, and two buttons that activate suction and sprayer functions. This nasal aspirator is powered by two AAA batteries. The accessories are the batteries, silicone tips.
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K Number
K242028Device Name
Nasal Aspirator (BC-021, BC-022, BC-023, BC-024, BC-025, BC-026)
Manufacturer
Dongguanshi Yiyingmei Technology Co., Ltd.
Date Cleared
2024-11-19
(131 days)
Product Code
BTA
Regulation Number
878.4780Why did this record match?
Product Code :
BTA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Nasal Aspirator is intended for intermittent removal of nasal secretions and mucus from children (age 2~12 years old). This device is used in a home environment.
Device Description
The Nasal Aspirator consists of silicone tips which has three models (A, B, C), host, tube, mucus collector. The accessory are charging cable-USB, clean brush, clip, sponge. The Nasal Aspirator is a portable device which is intended for suction of nasal passages in children 2-12 years of age.
The motor pump provides a negative pressure which removes nasal secretions.The motor pump operates on a rechargeable battery. The rechargeable battery can be charged from the exter (not included in this device) through the provided charging line. The user interface consists of buttons and indicator/ display, and the vacuum pressure through the button. Three different shapes of silicone nasal tips are provided to enable easier and more effective removal of the nasal mucus.
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K Number
K241202Device Name
Electric nasal aspirator (HTD2601US)
Manufacturer
Hetaida Technology Co., Ltd.
Date Cleared
2024-07-01
(62 days)
Product Code
BTA
Regulation Number
878.4780Why did this record match?
Product Code :
BTA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Electronic Nasal Aspirator is intended for intermittent removal of nasal secretions and mucus from children (age 2-12 years old). This device is used in a home environment.
Device Description
Electric nasal aspirator consists of main unit, and the suction portion working together as one unit. The Electronic Nasal Aspirator is a portable device which is intended for suction of nasal passages in children 2-12 years of age. The motor pump provides a negative pressure which removes nasal secretions. The motor pump operates on a rechargeable battery. The rechargeable battery can be charged from the external power adapter (not included in this device) through the provided charging line. The user interface consists of buttons and LED display, and the user can control the vacuum pressure through the button.
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K Number
K233901Device Name
Baby Nasal Aspirator (KA1006, KA1001, KA1005, NASA005, NASA006, NASA008, NASA009)
Manufacturer
Shenzhen Desida Technology Co., Ltd.
Date Cleared
2024-03-20
(100 days)
Product Code
BTA
Regulation Number
878.4780Why did this record match?
Product Code :
BTA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Baby Nasal Aspirator is intended for intermittent removal of nasal secretions and mucus from children (age 2~12 years old). This device is ued in a home environment.
Device Description
The Baby Nasal Aspirator is intended for intermittent removal of nasal secretions and mucus from children (age 2~12 years old). This device is used in a home environment. It consists of main unit, and suction working together as one unit. The Baby Nasal Aspirator is a portable device which is intended for suction of nasal passages in children 2-12 years of age. The motor provides a negative pressure which removes nasal secretions. The motor pump operates on a rechargeable battery. The recharged from the external power adapter(not included in this device) through the provided charging line. The user interface consists of buttons and the user can control the vacuum pressure through the button.
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