ACR 2500 Cardiotomy Reservoir Filter
510(k) K842391
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK842391 | Date21 May 1985 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- DTN
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.4400
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The ACR 2500 Cardiotomy Reservoir Filter is a Blood, Cardiopulmonary Bypass Reservoir designed for use during cardiopulmonary bypass procedures. It functions as a collection and filtration system for blood aspirated from the heart and pericardial cavity, ensuring particulate matter is removed before reinfusion into the patient’s circulation. This device integrates filtration capabilities directly into the reservoir to maintain blood safety and reduce clotting risks during surgery.
Supplied as a single-use, sterile device, the ACR 2500 is intended for use in controlled surgical environments such as operating rooms. It adheres to FDA Class II regulatory standards under 510(k) clearance (K842391), with a substantially equivalent determination by the Cardiovascular (CV) Advisory Committee. The device is manufactured by Electromedics, Inc., and its specifications align with regulation number 870.4400, ensuring compliance with blood reservoir and filtration requirements for cardiothoracic procedures.