# K130039: Revaclear 300 Dialyzer, Revaclear 400 Dialyzer

- Pathway: 510(k) (Traditional)
- Applicant: Gambro Renal Products, Inc.
- Decided: May 2, 2013 after 115 days
- Product code: KDI (Dialyzer, High Permeability With Or Without Sealed Dialysate System)
- Device class: 2
- Regulation: 21 CFR 876.5860
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K955592 (1997). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060195: Gambro Polyflux HD-C4 Capillary Dialyzer/Filter for Single Use, Gambro Renal Products (2006) Summary page 1.
- K072232: Gambro Polyflux Hemodialyzer, Model: HD-C4 Small, Gambro Renal Products, Inc. (2007) Summary page 1.

## Recalls of this device
- Nov 23, 2022 · Class II · Z-0760-2023: Potential for Internal Blood Leaks due to a twisted gasket in the dialyzer
- Nov 23, 2022 · Class II · Z-0763-2023: Reports of Polyurethane Displacement in the dialyzer, and might be identified as a blood leak
- Nov 23, 2022 · Class II · Z-0764-2023: Reports of Polyurethane Displacement in the dialyzer, and might be identified as a blood leak
- Nov 23, 2022 · Class II · Z-0762-2023: Reports of Polyurethane Displacement in the dialyzer, and might be identified as a blood leak
- Nov 15, 2019 · Class II · Z-1409-2020: There is the potential presence of particular matter in the header caps of ten lots the Revaclear 300 Dialyzer.
- May 31, 2019 · Class II · Z-1908-2019: There is a potential presence of ruptured dialyzer fibers which may lead to a blood leak during treatment.
- May 31, 2019 · Class II · Z-1909-2019: There is a potential presence of ruptured dialyzer fibers which may lead to a blood leak during treatment.

## Indications for use
Revaclear 300 and 400 dialyzers are indicated for treatment of chronic and acute renal failure by hemodialysis.

Source page: https://510kreport.com/device/K130039
Methodology: https://510kreport.com/methodology