DIGI -FLOW
by D and D Technology, Inc. 510(k)
Active
510(k) K920671
Overview
This device is an accessory for blood circuit hemodialysis, as defined in the device name and specifications. It is classified as a Class II medical device under regulation number 876.5820.
The device received FDA 510(k) clearance (K920671) on January 28, 1993, following a traditional review process. It was found substantially equivalent and reviewed by the Gastroenterology and Urology advisory committee. The manufacturer is D and D Technology, Inc., located in Buffalo, NY.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK920671 | Date28 Jan 1993 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- KOC
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.5820
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Questions
What is the DIGI -FLOW device used for?
The DIGI -FLOW is an accessory for blood circuit hemodialysis, designed to support the function of hemodialysis systems as specified in its device name and classification under regulation 876.5820.
How was the DIGI -FLOW cleared for market?
The DIGI -FLOW received FDA 510(k) clearance (K920671) on January 28, 1993, through a traditional review process, after being determined substantially equivalent to a predicate device by the Gastroenterology and Urology advisory committee.
Who manufactures the DIGI -FLOW and where are they located?
The DIGI -FLOW is manufactured by D and D Technology, Inc., located at 693 Seneca St., Buffalo, NY 14210, United States, as listed in the device’s registration and clearance records.