FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
O.22/UM FILTERSET W/FLASHBACK
K Number: K770183
·
Decision Feb 9, 1977
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
97
Applicant Total
883
Review Days
13
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
- O.22/UM FILTERSET W/FLASHBACK
- K Number
- K770183
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Abbott Laboratories
- Date Received
- January 27, 1977
- Decision Date
- February 9, 1977
- 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 Abbott Laboratories
| K Number | Device Name | ||
|---|---|---|---|
| K252424 | Anti-HCV Next | Apr 28, 2026 | Substantially Equivalent |
| K243500 | ARCHITECT iGentamicin | Jul 9, 2025 | Substantially Equivalent |
| K243168 | Alinity i Rubella IgG | Jun 20, 2025 | Substantially Equivalent |
| K243283 | Alinity h-series System | Feb 20, 2025 | Substantially Equivalent |
| K233932 | Alinity i Toxo IgM | Aug 30, 2024 | Substantially Equivalent |
| K232669 | TBI | Sep 29, 2023 | Substantially Equivalent |
| K222850 | HAVAb IgG II | Aug 10, 2023 | Substantially Equivalent |
| K220031 | Alinity h-series System | Aug 4, 2023 | Substantially Equivalent |
| K220282 | i-STAT PTplus Cartridge with the i-STAT 1 System | Jul 14, 2023 | Substantially Equivalent |
| K230937 | Alinity i Total ß-hCG Reagent Kit, GLP systems Track | Jun 5, 2023 | Substantially Equivalent |