# K823115: Naturalyte Bicarbonate Dialysate 4400

- Pathway: 510(k) (Traditional)
- Applicant: Erika, Inc.
- Decided: Dec 3, 1982 after 43 days
- Product code: KRO (Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3510
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K070177: Fresenius Naturalyte Liquid Acid Concentrate, 9000, 6000 and 4000 Series (2007), 0 descendants of its own

Source page: https://510kreport.com/device/K823115
Methodology: https://510kreport.com/methodology