BT-795/ATS Autotransfusion Apparatus
510(k) K871847
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK871847 | Date19 Jun 1987 | 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- Withdrawn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
- Full name
- Bt-795/Ats
- 510(k) Number
- FDA Product Code
- CAC
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.5830
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The BT-795/ATS is an Apparatus, Autotransfusion designed for the collection, processing, and reinfusion of a patient’s own blood during surgical procedures. It facilitates intraoperative autotransfusion by filtering and returning shed blood to the patient, reducing the need for allogeneic transfusions and associated risks.
This device is intended for single-use in operating room settings and requires sterile handling. It is classified as a Class II medical device under FDA regulation 868.5830 and has received FDA 510(k) clearance (K871847). The apparatus is supplied as a complete, ready-to-use system and must be used in accordance with manufacturer instructions to ensure proper functionality and patient safety.
Other devices from Electromedics, Inc.
Questions
AI-generated answers, 19 Sep 2026
What is the BT-795/ATS used for in the operating room?
The BT-795/ATS is designed specifically for intraoperative autotransfusion, which means it collects, processes, and returns a patient’s own shed blood during surgery. This reduces the need for allogeneic blood transfusions and lowers associated risks, such as immune reactions or infections. It’s particularly useful in procedures where significant blood loss is expected.
Is the BT-795/ATS intended for reuse or single-use, and how should it be handled?
The BT-795/ATS is explicitly designed for single-use only in sterile operating room settings. Since it’s intended for direct patient contact with blood, it must be handled as a sterile device to prevent contamination. Always follow the manufacturer’s instructions for setup, use, and disposal to ensure patient safety.
What regulatory pathway was followed for FDA clearance of the BT-795/ATS?
The BT-795/ATS received FDA 510(k) clearance under the traditional review pathway, with a decision date of June 19, 1987. It was classified as a Class II medical device under regulation 21 CFR 868.5830 and was reviewed by the Anesthesiology (AN) Advisory Committee. The clearance was granted as substantially equivalent to a predicate device.
How is the BT-795/ATS supplied, and what does a complete system include?
The BT-795/ATS is supplied as a complete, ready-to-use system by Electromedics, Inc. This means all necessary components for intraoperative autotransfusion—including collection bags, filters, tubing, and connectors—are pre-packaged and sterile. No additional assembly is required beyond following the manufacturer’s instructions for setup.
What medical specialty is primarily associated with the use of the BT-795/ATS?
The BT-795/ATS is primarily associated with the Anesthesiology specialty, as indicated by its regulatory submissions. This reflects its role in intraoperative blood management, where anesthesiologists often oversee transfusion protocols and patient monitoring during surgery.