# K830575: Renalin (Tentative

- Pathway: 510(k) (Traditional)
- Applicant: Renal Systems, Inc.
- Decided: Mar 31, 1983 after 36 days
- Product code: LIF (Dialyzer Reprocessing System)
- 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
No predicates in its family tree.
5 later devices descend from it; 2 cite it directly.
0 of 6 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
- K043207: Ozone Generator (2005), 4 descendants of its own
- K093641: TANGO3 Water Storage Tank with Ozone Disinfection System (2010), 3 descendants of its own
- K140984: TANGO3 Water Storage Tank with Ozone Disinfection System (2015), 0 descendants of its own
- K141213: Ameriwater Ozone Disinfection System (2014), 0 descendants of its own
- K142285: AmeriWater Heatsan, 3-phase, 208v, 60hz, AmeriWater Heatsan, 3-phase, 460V, 60hz, Ameriwater Heatsan, 3-phase, 575v, 60hz (2014), 0 descendants of its own

Source page: https://510kreport.com/device/K830575
Methodology: https://510kreport.com/methodology