# K081043: Leak Detection Sensor and Tray Accessory Kit

- Pathway: 510(k) (Traditional)
- Applicant: Nxstage Medical, Inc.
- Decided: Jul 7, 2008 after 84 days
- Product code: KOC (Accessories, Blood Circuit, Hemodialysis)
- 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: 3 generations back to K921456 (1994). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043436: Nxstage Dialysate Preparation Module, Model NX0269, Nxstage Medical, Inc. (2005) Summary page 2.
- K010131: PHD Personal Hemodialysis Instrument-1M101, PHD Water Pre-Treatment Kit-1W605,PHD Hard Plumbing Kit-1W604, PHD Blood Tub, Aksys, Ltd. (2002) Summary page 2.
- K844866: Nytone Enuretic Alarm Bedwetting Device, Nytone Medical (1985) Summary page 2.

## Indications for use
The leak detection sensor and tray provide a means of detecting fluid leaks when used as an accessory to the NxStage System One.

Source page: https://510kreport.com/device/K081043
Methodology: https://510kreport.com/methodology