# K962959: Peracidin Dialyzer Reprocessing Concentrate

- Pathway: 510(k) (Traditional)
- Applicant: Hdc Medical, Inc.
- Decided: Jun 5, 1998 after 675 days
- Product code: MED (Sterilant, Medical Devices)
- Device class: 2
- Regulation: 21 CFR 880.6885
- 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 K882564 (1989). 1 ancestor in all.
4 later devices descend from it; 1 cites 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)
- K882564: Renalin Cold Sterilant, Minntech Corp. (1989) Summary page 1.

## Most influential descendants
- 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

## Indications for use
Peracidin Dialyzer Reprocessing Concentrate is indicated for the in vitro cleaning and disinfection of hollow fiber dialyzers The product is intended for use only with dialyzer reprocessing systems, automated or manual, that have been validated for use with peracetic acid.

Source page: https://510kreport.com/device/K962959
Methodology: https://510kreport.com/methodology