FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Disposable Neonatal NIBP Cuff (U1682S-C51N); Disposable Neonatal NIBP Cuff (U1683S-C51N); Disposable Neonatal NIBP Cuff (U1684S-C51N); Disposable Neonatal NIBP Cuff (U1685S-C51N)
K Number: K251045
·
Decision Jul 15, 2025
Classifications
1
FEI Numbers
172
Registration Numbers
172
Same Product Code
197
Applicant Total
20
Review Days
103
Basic Information
- 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)
- K Number
- K251045
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1120
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Unimed Medical Supplies, Inc.
- Date Received
- April 3, 2025
- Decision Date
- July 15, 2025
- 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.
YP-710T Series NIBP Cuff;YP-840T Series Disposable Cuff
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FDA Class 2
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FDA Class 2
·Cardiovascular
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FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Unimed Medical Supplies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K253162 | Temperature probes (T2252-PG); Temperature probes (TCMA-AG); Temperature probes (TCMA-PG); Temperature probes (TMQ-DAG); Temperature probes (THP-DAG) | Jun 5, 2026 | Substantially Equivalent |
| K260931 | Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R) | Apr 14, 2026 | Substantially Equivalent |
| K253964 | Disposable Neonatal NIBP Cuff (U1681S-C51N) | Jan 9, 2026 | Substantially Equivalent |
| K251696 | Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48); Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-29) | Dec 1, 2025 | Substantially Equivalent |
| K251691 | Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U203S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U103S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U103-08) | Dec 1, 2025 | Substantially Equivalent |
| K251693 | Unimed Reusable SpO2 Sensors (-75 Series) (U410-75); Unimed Reusable SpO2 Sensors (-75 Series) (U110-75); Unimed Reusable SpO2 Sensors (-75 Series) (U410S-75); Unimed Reusable SpO2 Sensors (-75 Series) (U110S-75); Unimed Reusable SpO2 Sensors (-75 Series) (U210S-75) | Nov 18, 2025 | Substantially Equivalent |
| K251695 | Unimed Reusable SpO2 Sensors (-06 Series) (U403S-06); Unimed Reusable SpO2 Sensors (-06 Series) (U203S-06); Unimed Reusable SpO2 Sensors (-06 Series) (U103S-06) | Nov 18, 2025 | Substantially Equivalent |
| K250931 | Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U403-117); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U103-117); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U410-121); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U110-121) | Aug 13, 2025 | Substantially Equivalent |
| K243086 | Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series) (U403-91); Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series) (U410-91) | Feb 20, 2025 | Substantially Equivalent |
| K242580 | Unimed Reusable Finger Clip SpO2 Sensors (U103-125); Unimed Reusable Finger Clip SpO2 Sensors (U403-254); Unimed Reusable Finger Clip SpO2 Sensors (U103-254); Unimed Reusable Finger Clip SpO2 Sensors (U403-125) | Feb 6, 2025 | Substantially Equivalent |