FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODEL 40-30-2 AIR ELIMINATING FILTER SET
K Number: K801614
·
Decision Aug 13, 1980
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
97
Applicant Total
78
Review Days
29
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
- MODEL 40-30-2 AIR ELIMINATING FILTER SET
- K Number
- K801614
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Y
- Date Received
- July 15, 1980
- Decision Date
- August 13, 1980
- 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 Y
| K Number | Device Name | ||
|---|---|---|---|
| K955846 | MODEL 2082 TEMP PLUS III THERMOMETER/MODEL 2087 TEMP PLUS III WALL MOUNT THERMOMETER | Oct 1, 1996 | Substantially Equivalent |
| K960280 | IVAC NEEDLE FREE VALVE ADMINISTRATION SETS | Apr 4, 1996 | Substantially Equivalent |
| K953225 | IVAC BALL VALCE ADMIN. SETS | Sep 27, 1995 | Substantially Equivalent |
| K934095 | IVAC VENTED SYRINGE ADAPTER ADMINISTRATION SETS | Aug 10, 1994 | Substantially Equivalent |
| K940897 | IVAC NEEDLELESS INFECTION VALVE ADMINISTRATION SET | Jun 22, 1994 | Substantially Equivalent |
| K931550 | EZ ADMINISTRATION SET | Jan 10, 1994 | Substantially Equivalent |
| K931549 | MODEL EZ-1 SING CHAN/EZ-2 DUAL CHANNEL INFUS PUMP | Oct 12, 1993 | Substantially Equivalent |
| K932544 | IVAC SPACE SAVER VOLUMETRIC PUMP, MODEL 599 | Oct 12, 1993 | Substantially Equivalent |
| K922115 | IVAC NEEDLELESS INJECTION VALVE | Oct 12, 1993 | Substantially Equivalent |
| K930781 | INFUSION PUMP | Aug 19, 1993 | Substantially Equivalent |