510(k) · Cleared
ClearedLeak Detection Sensor and Tray Accessory Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nxstage Medical, Inc. · KOC Accessories, Blood Circuit, Hemodialysis
Cleared on Jul 7, 2008 as substantially equivalent to K043436 (Nxstage Medical, Inc., 2005) and 2 other predicates after an 84-day review. Its family tree reaches back 3 generations to 1994.
- Decided
- Jul 7, 2008
- Review
- 84 days
- Class
- Class II
- Product code
- KOC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K921456 (1994). 17 ancestors in all, the oldest K770691 (1977). No later device cites it as a predicate yet.
- Root · 3 generations backK921456 Fresenius 3008/FDS-08 Dialysate Delivery SystemFresenius USA, Inc. · 1994 · Recalled
- 2 generations backK994267 Fresenius 2008KFresenius Medical Care · 2000 · Recalled
- 1 generation backK043436 Nxstage Dialysate Preparation Module, Model NX0269Nxstage Medical, Inc. · 2005
- This deviceK081043 Leak Detection Sensor and Tray Accessory KitNxstage Medical, Inc. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K921456 | Fresenius 3008/FDS-08 Dialysate Delivery System | Fresenius USA, Inc. | 1994 | 3 |
| −2 | K994267 | Fresenius 2008K | Fresenius Medical Care | 2000 | 5 |
| −1 | K043436 | Nxstage Dialysate Preparation Module, Model NX0269 | Nxstage Medical, Inc. | 2005 | — |
| 0 (this device) | K081043 | Leak Detection Sensor and Tray Accessory Kit | Nxstage Medical, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1977 | 1 | 0 |
| 1981 | 2 | 0 |
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 2 | 0 |
| 1990 | 1 | 0 |
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 2002 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KOC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KOC device
- #1 K230514 Blood Tubing Lines for Hemodialysis AL Series…score 11.8 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K043436 | Nxstage Dialysate Preparation Module, Model NX0269Summary page 2…d tray are substantially equivalent to: Device Name Manufacturer 510(K) PureFlow SL NxStage Medical, Inc. K043436 Aksys PHD Personal Aksys, LTD K010131 Hemodialysis System Nytone Enuretic Alarm… | 2005 |
| * | K010131 | PHD Personal Hemodialysis Instrument-1M101, PHD Water Pre-Treatment Kit-1W605,PHD Hard…Summary page 2…Manufacturer 510(K) PureFlow SL NxStage Medical, Inc. K043436 Aksys PHD Personal Aksys, LTD K010131 Hemodialysis System Nytone Enuretic Alarm Nytone Medical K844866 Bedwetting Device D. Device De… | 2002 |
| * | K844866 | Nytone Enuretic Alarm Bedwetting DeviceSummary page 2…Inc. K043436 Aksys PHD Personal Aksys, LTD K010131 Hemodialysis System Nytone Enuretic Alarm Nytone Medical K844866 Bedwetting Device D. Device Description/Indications for Use: The NxStage leak detection sensor and tray is designed for… | 1985 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 5.0 years on median.
- 3 of the 17 ancestors have a recall of any class.
- 1 other device also cites its predicate K043436.
How does its category compare?
All KOC devicesKOC Accessories, Blood Circuit, Hemodialysis: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · KOC
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KOC
Too few KOC 510(k)s in any year since 2007 to give a median.
Recalls per year · KOC
4so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KOC
50in 2025
MAUDE reports naming product code KOC, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 3 |
| 2008 | 2 | — | 2 | 12 |
| 2009 | 2 | — | 0 | 12 |
| 2010 | 0 | — | 0 | 4 |
| 2011 | 0 | — | 0 | 10 |
| 2012 | 1 | — | 1 | 2 |
| 2013 | 0 | — | 0 | 22 |
| 2014 | 1 | — | 1 | 165 |
| 2015 | 2 | — | 0 | 555 |
| 2016 | 1 | — | 0 | 10 |
| 2017 | 1 | — | 0 | 23 |
| 2018 | 0 | — | 3 | 37 |
| 2019 | 0 | — | 0 | 56 |
| 2020 | 1 | — | 0 | 20 |
| 2021 | 0 | — | 0 | 33 |
| 2022 | 0 | — | 0 | 26 |
| 2023 | 2 | — | 0 | 16 |
| 2024 | 0 | — | 0 | 18 |
| 2025 | 2 | — | 0 | 50 |
| 2026 | 0 | — | 4 | — |
What is it indicated for?
The leak detection sensor and tray provide a means of detecting fluid leaks when used as an accessory to the NxStage System One.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081043 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081043: Leak Detection Sensor and Tray Accessory Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081043
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026