Porous Media DPB20 Series Disposable Pre-bypass Filter
510(k) K982385
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK982385 | Date1 Feb 1999 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- KRJ
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.4280
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 21 Sep 2026
The Porous Media DPB20 Series Disposable Pre-bypass Filter is a cardiopulmonary bypass pre-bypass filter designed for use in extracorporeal circuits. It functions to filter non-cellular priming fluids prior to the initiation of cardiopulmonary bypass.
This single-use device is intended for operation by perfusionists or clinical staff within surgical settings and is discarded immediately following circuit priming. The device has received FDA 510(k) clearance and is classified as a Class II medical device under regulation number 870.4280.
Other devices from Porous Media Corp.
Questions
AI-generated answers, 21 Sep 2026
What is the primary function of the DPB20 Series filter?
This device is designed for use in extracorporeal circuits to filter non-cellular priming fluids. It is utilized specifically prior to the initiation of cardiopulmonary bypass to ensure the priming fluid is prepared for the procedure.
Is the DPB20 Series filter intended for reuse?
No, this is a single-use device. It must be discarded immediately following the circuit priming process to maintain clinical safety and prevent cross-contamination within the surgical setting.
Who is authorized to operate this filtration device?
The filter is intended for operation by perfusionists or qualified clinical staff who are responsible for managing extracorporeal circuits within a surgical environment.
What is the regulatory status of the Porous Media DPB20 Series?
The device has received FDA 510(k) clearance. It is classified as a Class II medical device under regulation number 870.4280, which pertains to cardiopulmonary bypass pre-bypass filters.