# K973253: Rockwell Medical Supply, LLC. Concentrate Solutions for Acetate Dialysate

- Pathway: 510(k) (Traditional)
- Applicant: International Medical Products, Inc.
- Decided: Oct 30, 1997 after 62 days
- Product code: KPO (Dialysate Concentrate For Hemodialysis (Liquid Or Powder))
- Device class: 2
- Regulation: 21 CFR 876.5820
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K864265 (1987). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K864265: Hemodialysis Bath Concentrate Solutions for Hemodi, Dial Medical of Florida, Inc. (1987). Our OCR of the scanned summary read K864285, FDA’s number for Terumo Ovation Spectrophotometer (Terumo Medical Corp.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Dial Medical, Inc. Acetate hemodialysis bath concentrate solutions”.

## Indications for use
The Rockwell Medical Supply Concentrate Solutions for Acetate Hemodialysis are indicated for use in acute and chronic hemodialysis and to be used with the appropriate hemodialysis machine/ monitor.

Source page: https://510kreport.com/device/K973253
Methodology: https://510kreport.com/methodology