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510(k) Data Aggregation
K Number
K250583Device Name
AdheResp Smart Breath-actuated Mesh Nebulizer
Manufacturer
Date Cleared
2025-06-20
(113 days)
Product Code
Regulation Number
868.5630Why did this record match?
Applicant Name (Manufacturer) :
HCmed Innovations Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The AdheResp Smart Breath-actuated Mesh Nebulizer is a system to aerosolize liquid medications for inhalation for patients ranging from pediatrics equal to or greater than 5 years old to adults who can coordinate breathing.
The environment of use are Hospital/institutional settings, home care use, schools, and long-term care facilities.
Device Description
The AdheResp Smart Breath-actuated Mesh Nebulizer consists of a main unit, medication reservoir, mouthpiece, key tag and charging cable, or power adapter. The medication reservoir could be further separated into a medication container and an aerosol chamber.
Principle of Operation: There are two key features in the AdheResp Smart Breath-actuated Mesh Nebulizer, which are vibrating mesh nebulization and breath-actuation functions. The AdheResp Smart Breath-actuated Mesh Nebulizer is an active mesh nebulizer. Active mesh nebulizers operate by electrically activating a piezoelectric (PZT) ceramic element that rapidly contracts and expands when applied a voltage to it. The vibrations of the PZT are transmitted to the mesh membrane, which is in contact with the liquid medication loaded in the medication container. This vibration pushes the liquid or suspension through the fine conical holes of the mesh, forming aerosol droplets for the user to inhale.
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K Number
K212649Device Name
Disposable Surgical Face Mask
Manufacturer
Date Cleared
2022-10-25
(428 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Lyncmed Medical Technology (Beijing) Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The disposable surgical face mask is intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and particulate materials.
Device Description
The proposed device, Disposable Surgical Face Mask is a three-layer, flat-folded mask. The mask body is made of 25g/m2 polypropylene (PP) non-woven cloth. The mask contains tie strings or ear loop to secure the mask over the users' mouth and face and includes a nosepiece to provide a firm fit over the nose. Ear loops are made of Polyurethane and spandex, and tie strings are made of polypropylene nonwoven cloth. The nose clip which is made of Iron-Zinc strip covered by polyethylene terephthalate (PET) covering. The disposable surgical face mask is available in two different specifications: 17.5×9.5cm and 16.5×8.5cm. The device is single use and provided sterile.
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K Number
K211586Device Name
Nitrile Examination Gloves (Blue, Violet)
Manufacturer
Date Cleared
2021-11-01
(161 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Lyncmed Medical Technology (Beijing) Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Nitrile Examination Gloves is a non-sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Device Description
The proposed device, Nitrile Examination Gloves (Blue, Violet) are disposable devices intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. The proposed devices are Powder Free Nitrile Examination Gloves and includes variations of different size and color. The color of the proposed device is Blue and Violet. The proposed device is not provided as sterilized. The proposed device is made of Nitrile.
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K Number
K202171Device Name
Pulmogine Vibrating Mesh Nebulizer
Manufacturer
Date Cleared
2021-07-01
(332 days)
Product Code
Regulation Number
868.5630Why did this record match?
Applicant Name (Manufacturer) :
HCMed Innovations Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Pulmogine® Vibrating Mesh Nebulizer is a system designed to aerosolize liquid medications for inhalation by the patient. The device may be used with pediatric (5 years and older), defined by the prescribed medication, and adult patients in hospital / institutional settings, home care use, schools, and long-term care facilities.
Device Description
The Pulmogine® Vibrating Mesh Nebulizer, whose dimensions are 74 mm (L) x 46 mm (W) x 96 mm (H), is a small, dumbbell-shaped, handheld, and internally powered general-purpose nebulizer which utilizes vibrating mesh technology to generate aerosol. The Pulmogine® Vibrating Mesh Nebulizer is designed for a single patient, multiple uses, and mainly composed of a Main Unit and a Medication Reservoir.
The Main Unit contains the control circuitry and the firmware to control the vibrating mesh module in the Medication Reservoir and is powered by 2 AA alkaline batteries or an AC adaptor.
The Medication Reservoir contains the nebulizing module (mesh) where the liquid medication will be turned into aerosols. The prescribed medication is added into the reservoir with ten (10) ml of medication capacity, nebulized, and inhaled through the aerosol port.
The Pulmogine® Vibrating Mesh Nebulizer generates aerosol from liquid medication during turning on through pressing ON/OFF button and turning off when pressing ON/OFF button again, auto-turn off when no liquid detected, or 10-minute session completed. There are different LED lights to monitor the status and operating condition of the nebulizer: green indicates power on and normally working, yellow flash indicates low power caution, and constant yellow indicates shut-off due to too low power.
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K Number
K182819Device Name
Decanting Device
Manufacturer
Date Cleared
2019-12-02
(424 days)
Product Code
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
Gcmedica Enterprise Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
GCMEDICA Mini Transfer Device, GCMEDICA Vial Transfer Device: Intended for the aseptic dispensing of solutions from IV containers. For use in transferring IV fluids/medication from a vial to an IV fluid administration device. GCMEDICA Bag Transfer Device, GCMEDICA Clear Bag Transfer Device: Intended for the aseptic dispensing of solutions from IV containers. For use in transferring IV fluids/medication from a bag to an IV fluid administration device.
Device Description
The Decanting Device is provided as sterile and is intended for use in a single procedure only. There are four proposed models: GC0652DD, GC 0653DD and GC0654DD and GC0654 DT. Model GC0652DD, GC0654DD and GC0654 DT consist of spike and cap for spike. Model GC0653DD consists of Protective Cap, Needle Tip, Cover and stick.
Through the use of a spike/stick, facilitates creation of a sterile fluid path. Decanting device help ensure an aseptic transfer or removal of fluids/medication from flexible and rigid containers.
For models GC0653DD and GC0652DD, insert the decanter spike/stick by piercing the rubber opening of the glass vial. Tilt the decanting device body until desired flow is reached, ensuring the spike/stick air ventilation holes remain inside the glass vial.
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K Number
K981157Device Name
STABLE FLOW
Manufacturer
Date Cleared
1998-06-16
(77 days)
Product Code
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
CMED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A device used to regulate the flow of fluids from a container, such as an I.V. bag, to a patient's vascular system, through a needle or catheter inserted into a vein. For single use.
Device Description
Stable Flow, I.V. Flow Controller
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