FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
YP-710T Series NIBP Cuff;YP-840T Series Disposable Cuff
K Number: K260747
·
Decision May 6, 2026
Classifications
1
FEI Numbers
172
Registration Numbers
172
Same Product Code
197
Applicant Total
19
Review Days
61
Basic Information
- Device Name
- YP-710T Series NIBP Cuff;YP-840T Series Disposable Cuff
- K Number
- K260747
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1120
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nihon Kohden Corporation
- Date Received
- March 6, 2026
- Decision Date
- May 6, 2026
- Product Code
- DXQ
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DXQ | Blood Pressure Cuff | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DXQ), ordered by most recent decision date.
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)
FDA 510(k)
FDA Class 2
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Disposable Neonatal NIBP Cuff (U1681S-C51N)
FDA 510(k)
FDA Class 2
·Cardiovascular
Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs)
FDA 510(k)
FDA Class 2
·Cardiovascular
AViTA Arm Type Blood Pressure Monitor Cuff
FDA 510(k)
FDA Class 2
·Cardiovascular
Disposable Neonatal NIBP Cuff (U1682S-C51N); Disposable Neonatal NIBP Cuff (U1683S-C51N); Disposable Neonatal NIBP Cuff (U1684S-C51N); Disposable Neonatal NIBP Cuff (U1685S-C51N)
FDA 510(k)
FDA Class 2
·Cardiovascular
Disposable Blood Pressure cuff; Reusable Blood Pressure cuff
FDA 510(k)
FDA Class 2
·Cardiovascular
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