FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SIMPLICITY EASY P SOFT INFUSION SET FOR INFUSION AND/OR INJECTION OF FLUIDS INTO THE BODY BELOW THE SURFACE OF THE SKIN
K Number: K021530
·
Decision May 21, 2002
Classifications
1
FEI Numbers
424
Registration Numbers
424
Same Product Code
1173
Applicant Total
27
Review Days
11
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
- SIMPLICITY EASY P SOFT INFUSION SET FOR INFUSION AND/OR INJECTION OF FLUIDS INTO THE BODY BELOW THE SURFACE OF THE SKIN
- K Number
- K021530
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sterling Medivations, Inc.
- Date Received
- May 10, 2002
- Decision Date
- May 21, 2002
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FPA), ordered by most recent decision date.
iiSure Infusion Set
FDA 510(k)
FDA Class 2
·General Hospital
AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)
FDA 510(k)
FDA Class 2
·General Hospital
PuraCath Firefly Needleless Connector IT (9005)
FDA 510(k)
FDA Class 2
·General Hospital
nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727]
FDA 510(k)
FDA Class 2
·General Hospital
BD Alaris Pump Infusion Set
FDA 510(k)
FDA Class 2
·General Hospital
EZ IV Administration Set
FDA 510(k)
FDA Class 2
·General Hospital
Other Clearances by Sterling Medivations, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K021487 | SIMPLICITY EASY ACCESS P INFUSION SET | May 17, 2002 | Substantially Equivalent |
| K021296 | SIMPLICITY QD EASY P INFUSION SET | May 14, 2002 | Substantially Equivalent |
| K021216 | SIMPLICTY SIMPLEX P INFUSION SET FOR USE WITH THE MINIMED PARADIGM INFUSION PUMPS | May 3, 2002 | Substantially Equivalent |
| K021005 | SIMPLICITY EASY ACCESS II INFUSION SET FOR INFUSION AND/OR INJECTION OF FLUIDS INTO THE BODY BELOW THE SURFACE | Apr 25, 2002 | Substantially Equivalent |
| K020990 | SIMPLICITY SOFT QD II INFUSION SET FOR INFUSION AND/OR INJECTION OF FLUIDS INTO THE BODY BELOW THE SURFACE OF THE SKIN | Apr 10, 2002 | Substantially Equivalent |
| K020912 | SIMPLICITY EASY SOFT INFUSION SET | Apr 10, 2002 | Substantially Equivalent |
| K020629 | SIMPLICITY SIMPLEX SOFT INFUSION SET | Apr 1, 2002 | Substantially Equivalent |
| K014062 | SIMPLICITY EASY ACCESS INFUSION SET | Jan 17, 2002 | Substantially Equivalent |
| K014061 | SIMPLICITY STARPLUS SOFT INFUSION SET | Jan 17, 2002 | Substantially Equivalent |
| K013767 | SIMPLICITY INFUSION RESERVOIR FOR USE TO INFUSE MEDICINE, INCLUDING INSULIN, FROM AN EXTERNAL INFUSION PUMP | Dec 12, 2001 | Substantially Equivalent |