FDA 510(k)
FDA class 2
Substantially Equivalent
🇧🇪 Belgium
K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB)
K Number: K251447
·
Decision Jul 8, 2025
Classifications
1
FEI Numbers
440
Registration Numbers
440
Same Product Code
687
Applicant Total
28
Review Days
60
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Basic Information
- Device Name
- K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB)
- K Number
- K251447
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5570
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Terumo Europe N.V.
- Date Received
- May 9, 2025
- Decision Date
- July 8, 2025
- Product Code
- FMI
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FMI | Needle, Hypodermic, Single Lumen | FDA class 2 | General Hospital |
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Other Clearances by Terumo Europe N.V.
| K Number | Device Name | ||
|---|---|---|---|
| K243309 | 27G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT) | May 29, 2025 | Substantially Equivalent |
| K243581 | K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC) | Apr 4, 2025 | Substantially Equivalent |
| K230951 | Terumo Injection Filter Needle (NF-3013RBKE05M) | Oct 18, 2023 | Substantially Equivalent |
| K212095 | SurGuard3 Safety Hypodermic Needle | Aug 22, 2022 | Substantially Equivalent |
| K192057 | K-Pack II Needle - 27G x 1/2 Extra Thin Wall, K-Pack II Needle - 27G x 1/2 Ultra Thin Wall, K-Pack II Needle - 30G x 1/2 Extra Thin Wall, K-Pack II Needle - 30G x 1/2 Ultra Thin Wall | Oct 11, 2019 | Substantially Equivalent |
| K161606 | Syringe with fixed needle - For use only with GONAL-F Multi-Dose 600 I/U mL FSH | Feb 10, 2017 | Substantially Equivalent |
| K151398 | K-Pack II Needle - 29G x 5/16 Thin Wall | Jun 25, 2015 | Substantially Equivalent |
| K150263 | K-Pack II Needle-21G x 2 | Apr 1, 2015 | Substantially Equivalent |
| K133894 | SURFLO WINGED INFUSION SET WITH FILTER & NEEDLE PROTECTION (SURSHIELD) | Mar 18, 2014 | Substantially Equivalent |
| K133867 | SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD) | Feb 5, 2014 | Substantially Equivalent |