Asahi Blood/Plasma Pump ABP-01A
510(k) K830818
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK830818 | Date12 Apr 1983 | 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- Withdrawn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
- FIR
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.5820
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Asahi Blood/Plasma Pump ABP-01A is an extra-luminal pump designed for the controlled extraction or infusion of blood or plasma. Classified as a Class II device under FDA regulation 876.5820, it is intended for use in gastroenterology and urology procedures, facilitating precise fluid management in clinical settings.
This device is supplied as a reusable medical instrument and requires appropriate sterilisation before use. It is cleared for MRI safety under the specified conditions outlined in its FDA 510(k) clearance (K830818), granted in 1983. The pump is intended for use in controlled clinical environments and adheres to traditional review standards, with no third-party involvement in its clearance process.
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Questions
AI-generated answers, 19 Sep 2026
What clinical specialties is the Asahi Blood/Plasma Pump primarily used in, and why is it designed for those areas?
The Asahi Blood/Plasma Pump #ABP-01A is primarily used in gastroenterology and urology procedures. It is designed for these specialties because it facilitates controlled extraction or infusion of blood or plasma during interventions where precise fluid management is critical, such as endoscopic or surgical procedures in these fields.
Is the Asahi Blood/Plasma Pump intended for single-use or reusable applications, and what sterilization requirements apply?
The Asahi Blood/Plasma Pump #ABP-01A is reusable and must undergo appropriate sterilization before each use to ensure safety and functionality. Since it is classified as a reusable medical instrument, proper sterilization protocols must be followed as per clinical guidelines.
How is the device cleared for use in clinical settings, and what does its FDA clearance status entail?
The Asahi Blood/Plasma Pump #ABP-01A holds an FDA 510(k) clearance (K830818), granted in 1983 under the Traditional Review pathway. It was determined to be substantially equivalent to a legally marketed device, meaning it meets FDA standards for safety and effectiveness as an extra-luminal blood/plasma pump for use in gastroenterology and urology. The clearance does not involve third-party review.
Can this pump be used in MRI environments, and if so, under what conditions?
Yes, the Asahi Blood/Plasma Pump #ABP-01A is cleared for MRI safety, but its use must comply with the specific conditions outlined in its FDA 510(k) clearance (K830818). Clinicians should refer to the device’s labeling or manufacturer instructions to ensure proper MRI compatibility and safety protocols are followed.
What types of fluids is this pump designed to handle, and how does its design support controlled fluid management?
The Asahi Blood/Plasma Pump #ABP-01A is specifically designed for the controlled extraction or infusion of blood or plasma. Its extra-luminal design allows for precise fluid management during procedures, ensuring accurate dosing and minimizing risks associated with manual handling or improper fluid control in clinical settings.