FlowSaver Blood Return System 80-101
510(k) K231782
Active
Valid until
No date given
FDA recalls
None foundTrust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK231782 | Date14 Jul 2023 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- 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, 18 Sep 2026
The FlowSaver Blood Return System 80-101 is an Apparatus, Autotransfusion designed for filtering and reinfusing aspirated blood and thrombi during surgical procedures. It collects blood drawn from the patient’s circulation, filters it through a 40 µm filter, and returns it to the patient’s venous system, thereby minimizing blood loss and preserving autologous blood volume.
This system is intended for use in anesthesiology procedures and is supplied as a single-use, non-sterile device. It requires connection to Inari Medical catheters and sheaths and is regulated under FDA 510(k) clearance and EU MDR. The reservoir volume is specified for the 80-101 model, and it must be used with appropriate anticoagulation. Storage and handling follow standard medical device protocols.
Other devices from Inari Medical, Inc.
Questions
AI-generated answers, 18 Sep 2026
What is the primary purpose of the FlowSaver Blood Return System (80-101) during surgical procedures?
The FlowSaver Blood Return System (80-101) is designed to collect aspirated blood and thrombi from a patient’s circulation during surgery, filter it through a 40 µm filter, and then reinfuse it into the patient’s venous system. This helps minimize blood loss and preserves the patient’s autologous blood volume, particularly in anesthesiology procedures.
Is the FlowSaver Blood Return System (80-101) intended for single-use or reusable applications?
The system is explicitly labeled as a single-use device, meaning it is not meant for reuse after a single surgical procedure. This aligns with standard medical device protocols to ensure patient safety and sterility.
How is the FlowSaver Blood Return System (80-101) supplied, and what accessories are required for use?
The device is supplied as a non-sterile system and must be used in conjunction with Inari Medical catheters and sheaths. It is not self-contained, requiring these additional components for proper functionality during surgical procedures.
What regulatory pathways does the FlowSaver Blood Return System (80-101) follow in the U.S. and EU?
In the U.S., the device is cleared via FDA 510(k) under a Special clearance type, classified as Class II (device class=2) and regulated under regulation number 868.5830. In the EU, it complies with MDR (Medical Device Regulation). Both pathways confirm its authorization for use in autotransfusion procedures.
Are there specific storage or handling requirements for the FlowSaver Blood Return System (80-101) before use?
While the data does not specify exact storage conditions, the system follows standard medical device protocols for handling. Since it is non-sterile, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures until ready for use, per typical industry practices.