FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SUB-Q SUBCUTANEOUS TISSUE INFUSION SET
K Number: K140131
·
Decision Apr 3, 2014
Classifications
1
FEI Numbers
424
Registration Numbers
424
Same Product Code
1173
Applicant Total
11
Review Days
76
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Basic Information
- Device Name
- SUB-Q SUBCUTANEOUS TISSUE INFUSION SET
- K Number
- K140131
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Emed Technologies Corporation
- Date Received
- January 17, 2014
- Decision Date
- April 3, 2014
- 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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Other Clearances by Emed Technologies Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K251105 | Tetra (TM-20); Tetra (TM-50) | Dec 22, 2025 | Substantially Equivalent |
| K240148 | SCIg60 Infusion System | Feb 16, 2024 | Substantially Equivalent |
| K230883 | VersaPump Infusion System | Nov 28, 2023 | Substantially Equivalent |
| K213429 | AccuSert Needle Inserter | Oct 20, 2022 | Substantially Equivalent |
| K222087 | SCIg60 Infusion System | Oct 13, 2022 | Substantially Equivalent |
| K173783 | SCIg60 Infusion System | Dec 14, 2018 | Substantially Equivalent |
| K161906 | SCIg60 Infuser | Dec 1, 2016 | Substantially Equivalent |
| K142319 | SCIg60 Infuser, Infuset | May 14, 2015 | Substantially Equivalent |
| K140133 | INFUSET FLOW CONTROL EXTENSION SET | May 15, 2014 | Substantially Equivalent |
| K123729 | VERSARATE FLOW RATE CONTROLER | Dec 21, 2012 | Substantially Equivalent |