DXQ — Blood Pressure Cuff

21 CFR 870.1120

Class 2

Definition

A blood pressure cuff is a device that has an inflatable bladder in an elastic sleeve (cuff) with a mechanism for inflating the bladder. The cuff is used to determine a subject's blood pressure.

Medical Specialty

CV

Review Panel

CV

Submission Type

1

FDA Authorisations (197)

Device Name K-Number
NIBP Cuff (BCS-112, BCS-212, BCS-312, BCS-412, BCS-512, BCS-612, BCS-712, BCS-122, BCS-222, BCS-322, BCS-422, BCS-522, BCS-622, BCS-722, BCD-112, BCD-212, BCD-312, BCD-412, BCD-512, BCD-612, BCD-712, BCD-122, BCD-222, BCD-322, BCD-422, BCD-522, BCD-622, BCD-722) K253089
Disposable Neonatal NIBP Cuff (U1681S-C51N) K253964
Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs) K251745
AViTA Arm Type Blood Pressure Monitor Cuff K250765
Disposable Neonatal NIBP Cuff (U1682S-C51N); Disposable Neonatal NIBP Cuff (U1683S-C51N); Disposable Neonatal NIBP Cuff (U1684S-C51N); Disposable Neonatal NIBP Cuff (U1685S-C51N) K251045
Disposable Blood Pressure cuff; Reusable Blood Pressure cuff K242623
Aneroid Sphygmomanometer with Stethoscope; Aneroid Sphygmomanometer K240165
Reusable Blood Pressure Cuff K233276
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) K232772
NIBPCuff K231961
Aneroid Sphygmomanometer K230859
ONE-CUF K230145
Aneroid Sphygmomanometer; Single Patient Use Aneroid Sphygmomanometer K222652
Disposable Blood Pressure Cuff K222420
Aneroid sphygmomanometer with stethoscope, QL-50, Aneroid sphygmomanometer, QL-20, Aneroid sphygmomanometer, QL-201 K221857
WX non-Automated Blood Pressure Meter,MODEL WX02, WX non-Automated Blood Pressure Meter with Stethoscope, MODEL WX0201, WX0202, WX0203 K212416
Aneroid Sphygmomanometer, Aneroid Sphygmomanometer with stethoscope K211084
Reusable NIBP Cuff K211747
Aneroid Sphygmomanometer K203620
Blood Pressure Cuff, U1883S,U1883D, U1882S, U1882D, U1881S, U1881D, Blood Pressure Cuff, U1885S, U1885D, U1880S, U1880D, U1886S, U1886D, Blood Pressure Cuff, U1869S, U1869D, U1889S, U1889D, U1884S, U1884D, Blood Pressure Cuff, U1710S, U1720S, U1730S,U1740S, U1750S, U1760S, Blood Pressure Cuff, U1770S, U1790s, U1710D, U1720D, U1730D, U1740D K203652
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