FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FLUID ADMINISTRATION SETS, 15 MICRON
K Number: K790314
·
Decision Mar 6, 1979
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
97
Applicant Total
48
Review Days
21
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
- FLUID ADMINISTRATION SETS, 15 MICRON
- K Number
- K790314
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Medex, Inc.
- Date Received
- February 13, 1979
- Decision Date
- March 6, 1979
- Product Code
- FPB
- 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 |
|---|---|---|---|
| FPB | Filter, Infusion Line | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FPB), ordered by most recent decision date.
Filter Needle for Single Use
FDA 510(k)
FDA Class 2
·General Hospital
Cathivex ¿GV filter units
FDA 510(k)
FDA Class 2
·General Hospital
NON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON FILTER
FDA 510(k)
FDA Class 2
·General Hospital
ARTERIA BLOOD FILTER
FDA 510(k)
FDA Class 2
·General Hospital
PALL SUPOR AEF FILTER
FDA 510(k)
FDA Class 2
·General Hospital
0.2 U BACTERIAL FILTER
FDA 510(k)
FDA Class 2
·General Hospital
Other Clearances by Medex, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K042432 | PHARMGUARD TOOLBOX, MODEL G6000782 | Jan 4, 2005 | Substantially Equivalent |
| K040899 | MEDEX 3000 SERIES MR SYRINGE INFUSION PUMP | Apr 30, 2004 | Substantially Equivalent |
| K020780 | TRANSTAR INTRACRANIAL PRESSURE TRANSDUCER, MODEL MX950ICP | May 20, 2002 | Substantially Equivalent |
| K000328 | MEDEX 3000 SERIES MRI COMPATIBLE SYRINGE INFUSION PUMP | May 9, 2000 | Substantially Equivalent |
| K982640 | MEDEX 3000 SERIES SYRINGE INFUSION PUMP | Apr 6, 1999 | Substantially Equivalent - Subject to Tracking Reg. |
| K982123 | CONTRAST CONTROL DEVICE | Jul 21, 1998 | Substantially Equivalent |
| K955231 | MEDFUSION MODEL 2001 SYRINGE INFUSION PUMP | Jul 18, 1996 | Substantially Equivalent - Subject to Tracking Reg. |
| K961404 | MX960 REUSABLE PRESSURE TRANSDUCER | Jun 27, 1996 | Substantially Equivalent |
| K961527 | MX703 AND MX730 CONTINUOUS FLUSH DEVICES | Jun 6, 1996 | Substantially Equivalent |
| K954970 | STOPCOCK & LUER LOCK PLUG | Apr 22, 1996 | Substantially Equivalent |