FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EFFECTIV (TM) CAP
K Number: K080579
·
Decision Sep 11, 2008
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
21
Applicant Total
45
Review Days
192
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
- EFFECTIV (TM) CAP
- K Number
- K080579
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hospira, Inc.
- Date Received
- March 3, 2008
- Decision Date
- September 11, 2008
- Product Code
- QBP
- 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 |
|---|---|---|---|
| QBP | Cap, Device Disinfectant | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (QBP), ordered by most recent decision date.
OTTO Disinfecting Cap
FDA 510(k)
FDA Class 2
·General Hospital
SteriHub Disinfecting Device and Protective Cover
FDA 510(k)
FDA Class 2
·General Hospital
ACTIV Cap
FDA 510(k)
FDA Class 2
·General Hospital
BD PureHub Disinfecting Cap
FDA 510(k)
FDA Class 2
·General Hospital
Curos Jet Disinfecting Cap
FDA 510(k)
FDA Class 2
·General Hospital
CapKlenZ
FDA 510(k)
FDA Class 2
·General Hospital
Other Clearances by Hospira, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K161469 | Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module | Mar 28, 2017 | Substantially Equivalent |
| K161036 | Hospira Extension Set, Hospira Primary Set | Jan 6, 2017 | Substantially Equivalent |
| K160492 | Hospira Sapphire Sets | Dec 6, 2016 | Substantially Equivalent |
| K160870 | Hospira Administration Sets | Jun 1, 2016 | Substantially Equivalent |
| K143612 | LifeCare PCA Infusion System | Apr 8, 2016 | Substantially Equivalent |
| K143087 | Hospira Blood Set | Mar 4, 2015 | Substantially Equivalent |
| K143015 | Hospira Primary Sets | Feb 25, 2015 | Substantially Equivalent |
| K141789 | PLUM 360 INFUSION SYSTEM WITH HOSPIRA MEDNET, SMART CARD PLUG N PLAY CE 3.0 MODULE FOR PLUM A+ INFUSION SYSTEM UPGRADE | Jan 16, 2015 | Substantially Equivalent |
| K142622 | IV Administration | Jan 15, 2015 | Substantially Equivalent |
| K142974 | Extension Sets | Jan 9, 2015 | Substantially Equivalent |