FDA 510(k)
FDA class 2
Substantially Equivalent
🇸🇬 Singapore
Safety Subcutaneous Infusion Set
K Number: K201626
·
Decision Mar 24, 2021
Classifications
1
FEI Numbers
424
Registration Numbers
424
Same Product Code
1173
Applicant Total
22
Review Days
281
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Basic Information
- Device Name
- Safety Subcutaneous Infusion Set
- K Number
- K201626
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Epic Medical Pte. , Ltd.
- Date Received
- June 16, 2020
- Decision Date
- March 24, 2021
- Product Code
- FPA
- 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 |
|---|---|---|---|
| FPA | Set, Administration, Intravascular | FDA class 2 | General Hospital |
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| K Number | Device Name | ||
|---|---|---|---|
| K252987 | ADRx Admixture Device | Jun 12, 2026 | Substantially Equivalent |
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| K251814 | EZ IV Administration Set | Aug 29, 2025 | Substantially Equivalent |
| K252094 | eZSURE Empty Fluid Container | Aug 1, 2025 | Substantially Equivalent |
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| K243976 | ZeroClear Bag Access (423100) | Jan 22, 2025 | Substantially Equivalent |
| K240517 | ProSeal Vented Universal Vial Adaptor | Dec 26, 2024 | Substantially Equivalent |
| K241988 | ProSeal Closed System Bag Access | Oct 23, 2024 | Substantially Equivalent |
| K241735 | ProSeal In Line Pump Set (423850) | Oct 10, 2024 | Substantially Equivalent |