# K070049: Fresenius 2008K @Home with Wireless Wetness Detector

- Pathway: 510(k) (Traditional)
- Applicant: Fresenius Medical Care North America
- Decided: Feb 3, 2011 after 1,491 days
- Product code: ONW (Hemodialysis System For Home Use)
- 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: 2 generations back to K921456 (1994). 2 ancestors in all.
13 later devices descend from it; 1 cites it directly.
3 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K994267: Fresenius 2008K, Fresenius Medical Care (2000) Summary page 2.

## Most influential descendants
- K121421: Fresenius 2008K Home Hemodialysis Machine with Wireless Wetness Detector (Wetalert) (2013), 12 descendants of its own
- K124035: 2008K@Home Hemodialysis Machine (2013), 11 descendants of its own
- K150708: 2008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, 2008T Hemodialysis Machine (2015), 9 descendants of its own
- K153449: 2008K2 Hemodialysis Machine (2016), 8 descendants of its own
- K173972: 2008T BlueStar Hemodialysis Machine (2018), 7 descendants of its own

## Recalls of this device
- Feb 20, 2015 · Class II · Z-1549-2015: The Acetate value for GranuFlo on the Select Concentrate screen should be 8mEq/l but it is displayed as 4mEq/l. The correct value is shown on the dialysate screen.
- Nov 12, 2013 · Class II · Z-0629-2014: 2008 Series Hemodialysis Machines complaints of saline bags inappropriately filling during recirculation and setup
- Aug 29, 2013 · Class II · Z-0186-2014: Updated Instructions for Use: Bloodline connections not tightened per instructions in the operator's manual may disconnect and lead to blood loss
- Aug 29, 2013 · Class II · Z-0184-2014: Updated Instructions for Use: Bloodline connections not tightened per instructions in the operator's manual may disconnect and lead to blood loss
- Aug 29, 2013 · Class II · Z-0185-2014: Updated Instructions for Use: Bloodline connections not tightened per instructions in the operator's manual may disconnect and lead to blood loss
- Aug 11, 2011 · Not classified · Z-3269-2011: Blood lines coiling tabs #1 and #5 on the arterial line are not in the correct positions
- May 4, 2011 · Not classified · Z-3083-2011: Upgrade software to implement new on screen graphics and instructions, the addition of a bracket on the side of the machine to temporarily hold the bloodlines during set up in order to conform to appr

## Indications for use
The Fresenius 2008K@home is indicated for acute and chronic dialysis therapy in an acute or chronic facility. The 2008K@home is also indicated for hemodialysis in the home and must be observed by a trained and qualified person as prescribed by their physician. The Wireless Wetness Detector is indicated for use with the Fresenius 2008K@home hemodialysis machine and is an optional accessory to aid in the detection of blood and water leaks during hemodialysis. Home hemodialysis using the detector must be observed by a trained and qualified person as prescribed by their physician.

Source page: https://510kreport.com/device/K070049
Methodology: https://510kreport.com/methodology