FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Remunity Pump for Remodulin (treprostinil) Injection
K Number: K202690
·
Decision Dec 30, 2020
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
3
Applicant Total
13
Review Days
106
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Basic Information
- Device Name
- Remunity Pump for Remodulin (treprostinil) Injection
- K Number
- K202690
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5725
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Deka Research and Development
- Date Received
- September 15, 2020
- Decision Date
- December 30, 2020
- Product Code
- QJY
- 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 |
|---|---|---|---|
| QJY | Infusion Pump, Drug Specific, Pharmacy-Filled | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (QJY), ordered by most recent decision date.
Remunity System
FDA 510(k)
FDA Class 2
·General Hospital
Remunity System
FDA 510(k)
FDA Class 2
·General Hospital
Unity Subcutaneous Infusion System for Remodulin
FDA 510(k)
FDA Class 2
·General Hospital
Other Clearances by Deka Research and Development
| K Number | Device Name | ||
|---|---|---|---|
| K261672 | twiist Automated Insulin Delivery (AID) System | Jun 17, 2026 | Substantially Equivalent |
| K261530 | iiSure Infusion Set | Jun 3, 2026 | Substantially Equivalent |
| K243841 | Sparta Infusion Set for Insulin | Aug 1, 2025 | Substantially Equivalent |
| K240920 | HemoCare Bicarbonate Concentrate Set (BCS) | Jul 12, 2024 | Substantially Equivalent |
| K233557 | HemoCare Hemodialysis System | Jul 12, 2024 | Substantially Equivalent |
| K240256 | Remunity System | Jun 12, 2024 | Substantially Equivalent |
| K241178 | DEKA ACE Pump System | May 24, 2024 | Substantially Equivalent |
| K234055 | DEKA Loop | Mar 13, 2024 | Substantially Equivalent |
| K233952 | DEKA ACE Pump System | Mar 13, 2024 | Substantially Equivalent |
| K232316 | DEKA Infusion System, DEKA Administration Set | Mar 1, 2024 | Substantially Equivalent |