FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
Sapphire Infusion Pump
K Number: K161667
·
Decision Mar 27, 2017
Classifications
1
FEI Numbers
149
Registration Numbers
149
Same Product Code
847
Applicant Total
5
Review Days
284
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
- Sapphire Infusion Pump
- K Number
- K161667
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5725
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Q Core Medical , Ltd.
- Date Received
- June 16, 2016
- Decision Date
- March 27, 2017
- Product Code
- FRN
- 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 |
|---|---|---|---|
| FRN | Pump, Infusion | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FRN), ordered by most recent decision date.
FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing
FDA 510(k)
FDA Class 2
·General Hospital
Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)
FDA 510(k)
FDA Class 2
·General Hospital
SIGMA Spectrum Infusion Pump with Master Drug Library
FDA 510(k)
FDA Class 2
·General Hospital
MRidium 3870 MRI Infusion Pump System (3870)
FDA 510(k)
FDA Class 2
·General Hospital
BD Alaris Infusion System with Guardrails Suite MX
FDA 510(k)
FDA Class 2
·General Hospital
Plum Solo Precision IV Pump
FDA 510(k)
FDA Class 2
·General Hospital
Other Clearances by Q Core Medical , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K192860 | Sapphire Infusion Pump, Sapphire administration sets | Nov 19, 2020 | Substantially Equivalent |
| K141389 | SAPPHIRE INFUSION PUMP | Dec 11, 2014 | Substantially Equivalent |
| K141834 | SAPPHIRE ADMINISTRATION SET | Aug 5, 2014 | Substantially Equivalent |
| K123049 | SAPPHIRE INFUSION PUMP | Oct 17, 2013 | Substantially Equivalent |