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510(k) Data Aggregation

    K Number
    K251045
    Device Name
    Disposable Neonatal NIBP Cuff (U1682S-C51N); Disposable Neonatal NIBP Cuff (U1683S-C51N); Disposable Neonatal NIBP Cuff (U1684S-C51N); Disposable Neonatal NIBP Cuff (U1685S-C51N)
    Manufacturer
    Unimed Medical Supplies, Inc.
    Date Cleared
    2025-07-15

    (103 days)

    Product Code
    DXQ
    Regulation Number
    870.1120
    Why did this record match?
    Product Code :

    DXQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K242623
    Device Name
    Disposable Blood Pressure cuff; Reusable Blood Pressure cuff
    Manufacturer
    Shenzhen Medke Technology Co., Ltd.
    Date Cleared
    2024-10-31

    (58 days)

    Product Code
    DXQ
    Regulation Number
    870.1120
    Why did this record match?
    Product Code :

    DXQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The reusable blood pressure cuff is an accessory used in conjunction with noninvasive blood pressure measurement systems. The cuff is non-sterile and may be reused. It is available in neonate, infant, child and adult sizes. The cuff is not designed, sold, or intended for use except as indicated. The disposable blood pressure cuff is an accessory used in conjunction with noninvasive blood pressure measurement systems. The cuff is non-sterile and for single-patient use. It is available in neonate size. The cuff is not designed, sold, or intended for use except as indicated.
    Device Description
    The device comprises tubing attached to an inelastic sleeve with an integrated inflatable bladder that is wrapped around the patient's limb and secured by hook and loop closure. The device tubing is connected to a non-invasive blood pressure measurement system. It is available in neonatal, infant, child and adult sizes. The subject device includes disposable blood pressure cuff and reusable blood pressure cuff and contains Cuff with/without bladder and single/dual tubes Air Hose.
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    K Number
    K240165
    Device Name
    Aneroid Sphygmomanometer with Stethoscope; Aneroid Sphygmomanometer
    Manufacturer
    Wenzhou Longwan Medical Device Factory
    Date Cleared
    2024-03-20

    (58 days)

    Product Code
    DXQ, DXO, LDE
    Regulation Number
    870.1120
    Why did this record match?
    Product Code :

    DXQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended to be used by medical professionals or in the home for the measurement of systolic and diastolic pressure on new borns, infants, children, young adults. The device is intended to be manually attached to a patient and manually inflated along with a manual method for detecting Korotkoff sounds.
    Device Description
    The ANEROID SPHYGMOMANOMETER and ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE are manual blood pressure monitor used to measure blood presure.It consists of a cuff,a inflation bulb,a pressure gauge, an air valve and a stethoscope(optional). Cuff: The cuff is made of a durable fabric and is wrapped around the upper arm of the patient. It inflates and deflates during the measurement process. The material of outside layer is nylon cloth. Inflation Bulb: The inflation bulb is a rubber bulb that connects to the cuff and is used to manually inflate the cuff with air. The material is Neoprene or Silicon rubber or Nature latex or PVC. Pressure Gauge: The pressure gauge is a circular dial with a needle that indicates the pressure within the cuff. It is calibrated in millimeters of mercury (mmHg) and shows the systolic and diastolic blood pressure readings. The material is Aluminum or ABS. Air Valve: The valve is a control mechanism that allows for the release of air from the cuff once the measurement is complete. Stethoscope: Although not a part of the device itself, a stethoscope is typically used in conjunction with an Aneroid Sphygmomanometer to listen for the blood flow sounds, known as Korotkoff sounds, in the brachial artery during the measurement. Three model are single head Stethoscope(Model: TY-S01),Dual Head Stethoscope(Model: TY-S05) and Spraque Rappaport Stethoscope(Model: TY-S04) individually.These stethoscopes are listed in FDA database.
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    K Number
    K233276
    Device Name
    Reusable Blood Pressure Cuff
    Manufacturer
    Suzhou Minhua Medical Apparatus Supplies Co., LTD
    Date Cleared
    2023-12-21

    (83 days)

    Product Code
    DXQ, DXO
    Regulation Number
    870.1120
    Why did this record match?
    Product Code :

    DXQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Reusable Blood Pressure Cuff is an accessory used in conjunction with non-invasive blood pressure measurement systems. The cuff is non-sterile and reusable. It is available in adult size.
    Device Description
    The proposed device is an accessory used in conjunction with non-invasive blood pressure measurement systems, and wrap around the patient's limb. The cuff is non-sterile and reusable. The model difference of the proposed device includes bladder type, tube, color, joint model and size.
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    K Number
    K232772
    Device Name
    Blood Pressure Cuff (1201D1,12L2D1,1202D1,12L3D1,1203D1,1204D1,1205D1,1206D1,1207D1-1#,1207D1-2#,1207D1-3#,1207D1-4#,1207D1-5#,1201B1,12L2B1,1202B1,12L3B1,1203B1,1204B1,1205B1,1206B1,1207B1-1#,1207B1-2#,,1207B1-3#,1207B1-4#,1207B1-5#,1201W2,12L2W2,1202W2,12L3W2,1203W2,1204W2,1205W2,1206W2 and 1207W2)
    Manufacturer
    Shenzhen Plinma Technology Co. Ltd.
    Date Cleared
    2023-11-29

    (79 days)

    Product Code
    DXQ, DXO
    Regulation Number
    870.1120
    Why did this record match?
    Product Code :

    DXQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The disposable blood pressure cuff is an accessory used in conjunction with noninvasive blood pressure measurement systems. The cuff is non-sterile and for single-patient use. It is available in neonatal, pediatric and adult sizes. The cuff is not designed, sold, or intended for use except as indicated. The reusable blood pressure cuff is an accessory used in conjunction with noninvasive blood pressure measurement systems. The cuff is non-sterile and may be reused. It is available in neonatal, pediatric and adult sizes. The cuff is not designed, sold, or intended for use except as indicated.
    Device Description
    The device comprises tubing attached to an inelastic sleeve with an integrated inflatable bladder that is wrapped around the patient's limb and secured by hook and loop closure. The device tubing is connected to a non-invasive blood pressure measurement system. The subject device is categorized into two types of models according to its usage. Reusable Blood Pressure Cuff models: 1201B1,12L2B1,1202B1,12L3B1,1204B1,1205B1,1206B1,1207B1-1#,1207B1-2#,1207B1- 3#,1207B1-4#,1207B15#,1201W2,12L2W2,1202W2,12L3W2,1203W2, 1204W2,1205W2,1206W2 and 1207W2 Disposable Blood Pressure Cuff models: 1201D1,12L2D1,1202D1,12L3D1,1204D1,1205D1,1204D1,1207D1-1#,1207D1-2#,1207D1- 3#,1207D1-4#,1207D1-5# Connector models: PLINMA-03-127-003, PLINMA-03-T, PLINMA-03-Z3
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    K Number
    K231961
    Device Name
    NIBPCuff
    Manufacturer
    Shenzhen SINO-K Medical Technology Co.,Ltd
    Date Cleared
    2023-08-30

    (58 days)

    Product Code
    DXQ
    Regulation Number
    870.1120
    Why did this record match?
    Product Code :

    DXQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The reusable blood pressure cuff is an accessory used in conjunction with noninvasive blood pressure measurement systems. The cuff is non-sterile and may be reused. It is available in neonate, infant, child and adult sizes. The cuff is not designed, sold, or intended for use except as indicated. The disposable blood pressure cuff is an accessory used in conjunction with noninvasive blood pressure measurement systems. The cuff is non-sterile and for single-patient use. It is available in neonate, infant, child and adult sizes. The cuff is not designed, sold, or intended for use except as indicated.
    Device Description
    The proposed device is an accessory used in conjunction with noninvasive blood pressure measurement systems. It is available in neonatal, infant, child and adult sizes. The proposed device includes disposable blood pressure cuff and reusable blood pressure cuff. Both disposable and reusable blood pressure cuff have the same structure, which contains Cuff with bladder and single-tube Air Hose.
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    K Number
    K230859
    Device Name
    Aneroid Sphygmomanometer
    Manufacturer
    Wenzhou Kangshun Medical Devices Co.,Ltd
    Date Cleared
    2023-06-28

    (91 days)

    Product Code
    DXQ, LDE
    Regulation Number
    870.1120
    Why did this record match?
    Product Code :

    DXQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The aneroid sphygmomanometer is intended to be used by medical professionals or in the home for the measurement of systolic and diastolic pressure on children or adults. The device is intended to a patient and manually inflated along with a manual method for detecting Korotkoff sounds.
    Device Description
    The product is a manual non-invasive aneroid sphygmomanometer which respectively uses an inflation cuff wrapped around the upper arm. The cuff is inflated and deflated by a manual inflation bulb. Besides a manometer (Aneroid gauge), the accessories of MODEL Ks-1222,Ks-1621,Ks-3201,Ks-2203 also includes one selected cuff, one inflation bulb, instruction manual and a vinyl bag. It is conjunction with Stethoscope when use.
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    K Number
    K230145
    Device Name
    ONE-CUF
    Manufacturer
    GE Medical Systems Information Technologies, Inc.
    Date Cleared
    2023-03-14

    (55 days)

    Product Code
    DXQ, DXO
    Regulation Number
    870.1120
    Why did this record match?
    Product Code :

    DXQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The blood pressure cuff is an accessory used in con-invasive blood pressure measurement systems. It is non-sterile, single-patient use. It is available in pediatric and adult sizes. The cuff is not designed, sold or intended for use except as indicated.
    Device Description
    ONE-CUF blood pressure cuffs are accessories used in conjunction with noninvasive blood pressure (NIBP) measurement systems to obtain a blood pressure measurement. Blood pressure cuffs are non-sterile and single-patient use and may not be reprocessed for use on additional patients. They are available in pediatric and adult sizes. The devices are not designed, sold or intended for use except as indicated. Blood pressure cuffs do not include serviceable parts or components. Non-Invasive Blood Pressure Cuffs incorporate an inflatable non-distensible bladder, sized to encircle a patient's limb. The cuff includes one or two flanges for attaching flexible tubing. This allows air to flow in and out of the cuff bladder for inflation and deflation. Inflation allows for occlusion of an artery to facilitate the measurement of automated noninvasive blood pressure (NIBP). The cuff tubes are terminated with connectors that allow for attachment to a blood pressure hose. This cuff will be offered with two different connection systems, bayonet and DINACLICK.
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    K Number
    K222652
    Device Name
    Aneroid Sphygmomanometer; Single Patient Use Aneroid Sphygmomanometer
    Manufacturer
    Cardicare Company, Ltd.
    Date Cleared
    2022-11-28

    (88 days)

    Product Code
    DXQ, DXO
    Regulation Number
    870.1120
    Why did this record match?
    Product Code :

    DXQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Aneroid Sphygmomanometer is intended to be used in a healthcare facility by medical professionals or in the home to measure systolic and diastolic pressure on children and adults. The device is intended to be manually attached to a patient and manually inflated, along with a manual method for detecting Korotkoff sounds. The Single Patient Use Aneroid Sphygmomanometer is intended to be used in a healthcare facility by medical professionals or in the home to measure systolic and diastolic pressure on children and adults. The device is intended to be manually attached to a patient and manually inflated, along with a manual method for detecting Korotkoff sounds.
    Device Description
    The Aneroid Sphygmomanometer is a non-invasive blood pressure measurement system for monitoring blood pressure levels. This Non-automated Sphygmomanometer uses an occluding cuff and an aneroid sphygmomanometer to measure pressure. The proposed device is OTC, non-invasive, non-automated, and non-sterile. The proposed device consists of an aneroid qauge, cuff, bladder, and inflation bulb. There are four models, including AS-ND-001, AS-ND-001LG, AS-ND-001CH, and AS-D-001. The differences between models are in the size, color, and material of the cuff. The Single Patient Use Aneroid Sphygmomanometer is intended to be manually attached to a patient and manually inflated, along with a manual method for detecting Korotkoff sounds. The proposed device is OTC, non-invasive, non-automated, and non-sterile. The proposed device consists of a manometer, cuff, and inflation bulb. There are four models: AS-SPU-W, AS-SPU-Y, AS-SPU-LG, and AS-SPU-CH. The differences between models are in the size and color of the cuff. Both types of aneroid sphygmomanometers use the same measurement method of the Korotkoff sounds method; they are all reusable same measurement range and accuracy. The single-patient use type is for single-patient multiple uses only to avoid cross infection. Both types of aneroid sphygmomanometer can be sold with/without optioned stethoscopes which have been listed with the FDA. The proposed device is Over-The-Counter use, non-sterile, reusable device.
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    K Number
    K222420
    Device Name
    Disposable Blood Pressure Cuff
    Manufacturer
    Wenzhou Xikang Medical Instruments Co., Ltd.
    Date Cleared
    2022-11-21

    (102 days)

    Product Code
    DXQ, DXO
    Regulation Number
    870.1120
    Why did this record match?
    Product Code :

    DXQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The disposable blood pressure cuff is an accessory used in conjunction with noninvasive blood pressure measurement systems. The cuff is non-sterile and for single-patient use. It is available in neonate, infant, child and adult sizes. The cuff is not designed, sold, or intended for use except as indicated.
    Device Description
    The subject device is an accessory used in conjunction with noninvasive blood pressure measurement systems. It is available in neonatal, infant, child and adult sizes. The subject device contains Cuff with bladder and Air Hose. Air hose has single tube and double tube. Wrapped the cuff around the patient's limb and secured by hook and loop closure. The device tubing is connected to a non-invasive blood pressure measurement system. The device is single use device, and which is made of non-woven fabrics & PVC (Cuff) and PVC (Air Hose), thereinto, the non-woven fabrics & PVC (Cuff) is the material used to contacting with the patient. The disposable blood pressure cuff has 22 models with different size for different population with different arm size, and the 11 models of 22 are use single tube of air hose and other 11 models are use double tube of air hose, which is used for different noninvasive blood pressure measurement system.
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