Microfiltration Set MF10
by Biotest-Serum-Institut 510(k)
Active
510(k) K770253
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK770253 | Date5 Apr 1977 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- CAK
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5440
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
A microfiltration set designed for filtering blood or similar fluids, as indicated by its device name and classification as a Microfilter, Blood Transfusion under FDA regulation 880.5440. The device consists of filtration tubes containing polypropylene microfiltration candles with defined pore sizes for particle removal.
Supplied as a set for use in general hospital settings, the Microfiltration Set MF10 received FDA 510(k) clearance (K770253) on April 5, 1977, and is classified as a Class II medical device. It is manufactured by Biotest-Serum-Institut and identified by product code CAK, with no indication of sterility, single-use status, or MRI safety provided in the data.
Other devices from Biotest-Serum-Institut
Questions
AI-generated answers, 1 Oct 2026
What is the Microfiltration Set MF10 used for?
The Microfiltration Set MF10 is designed for filtering blood or similar fluids to remove particles, as indicated by its classification as a Microfilter, Blood Transfusion under FDA regulation 880.5440, and consists of filtration tubes containing polypropylene microfiltration candles with defined pore sizes for particle removal.
How is the Microfiltration Set MF10 supplied and for what setting is it intended?
The Microfiltration Set MF10 is supplied as a set for use in general hospital settings, as stated in the device description, and is intended for filtering blood or similar fluids in such environments.
Is the Microfiltration Set MF10 sterile or single-use?
The provided data does not indicate whether the Microfiltration Set MF10 is sterile or single-use, as no information on sterility, single-use status, or reuse is included in the device specifications or description.
What regulatory pathway was used for the Microfiltration Set MF10?
The Microfiltration Set MF10 received FDA 510(k) clearance (K770253) on April 5, 1977, through a traditional submission process, and was found substantially equivalent to a predicate device, as indicated by the decision code SESE and clearance type Traditional.