FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
JMS Harmony A.V. Fistula Needle Set
K Number: K151017
·
Decision May 13, 2015
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
78
Applicant Total
9
Review Days
27
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- JMS Harmony A.V. Fistula Needle Set
- K Number
- K151017
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 876.5540
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- JMS North America Corporation
- Date Received
- April 16, 2015
- Decision Date
- May 13, 2015
- Product Code
- FIE
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| FIE | Needle, Fistula | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FIE), ordered by most recent decision date.
JMS CAVEO A.V. Fistula Needle Set
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DORA Disposable A.V. Fistula Needle Sets
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol Disposable AV Fistula Needle Set (Safety Series)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DORA Disposable A.V. Fistula Needle Sets
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ANGEL TIP SAFETY INTRAVASCULAR NEEDLE SET
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
JMS SysLoc MINI A.V. Fistula Needle Set (V4), JMS SysLoc MINI Apheresis Needle Set (V4)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by JMS North America Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K251877 | JMS CAVEO A.V. Fistula Needle Set | Aug 15, 2025 | Substantially Equivalent |
| K172499 | NEOSHIELD | Jun 1, 2018 | Substantially Equivalent |
| K142564 | JMS SysLoc MINI A.V. Fistula Needle Set (V4), JMS SysLoc MINI Apheresis Needle Set (V4) | Dec 23, 2014 | Substantially Equivalent |
| K132321 | JMS SYRINGE | Feb 20, 2014 | Substantially Equivalent |
| K121488 | JMS SAFE WING CATH (SWC) | Mar 5, 2013 | Substantially Equivalent |
| K112178 | JMS APHERESIS NEEDLE SET WINGEATER(R) V2 | Oct 27, 2011 | Substantially Equivalent |
| K111948 | WINGEATER V2 | Oct 24, 2011 | Substantially Equivalent |
| K110157 | SYSLOC MINI V3 | Feb 11, 2011 | Substantially Equivalent |