FDA 510(k)
FDA class 2
Substantially Equivalent
🇸🇬 Singapore
ProSeal In Line Pump Set (423850)
K Number: K241735
·
Decision Oct 10, 2024
Classifications
1
FEI Numbers
40
Registration Numbers
40
Same Product Code
40
Applicant Total
22
Review Days
115
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Basic Information
- Device Name
- ProSeal In Line Pump Set (423850)
- K Number
- K241735
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Epic Medical Pte. , Ltd.
- Date Received
- June 17, 2024
- Decision Date
- October 10, 2024
- Product Code
- ONB
- 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 |
|---|---|---|---|
| ONB | Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System | FDA class 2 | General Hospital |
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Other Clearances by Epic Medical Pte. , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K252987 | ADRx Admixture Device | Jun 12, 2026 | Substantially Equivalent |
| K250234 | SMARTeZ Elastomeric Infusion Pump (RS series) | Apr 24, 2026 | Substantially Equivalent |
| K251722 | ProSeal Transfer Injector (421120, 421130, 421140) | Dec 5, 2025 | Substantially Equivalent |
| K251814 | EZ IV Administration Set | Aug 29, 2025 | Substantially Equivalent |
| K252094 | eZSURE Empty Fluid Container | Aug 1, 2025 | Substantially Equivalent |
| K251340 | ProSeal Bag Spike with Additive Port (423370ST, 423370) | May 29, 2025 | Substantially Equivalent |
| 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 |
| K242152 | SMARTeZ Elastomeric Infusion Pump (498111, 498121, 498131, 498141) | Oct 7, 2024 | Substantially Equivalent |