510(k) · Cleared
ClearedAdaptor HR-3000 Reuse
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Colorado Medical, Inc. · LIF Dialyzer Reprocessing System
Cleared on Jul 16, 1984 after a 119-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 14 later devices descend from it.
- Decided
- Jul 16, 1984
- Review
- 119 days
- Class
- Class II
- Product code
- LIF
- Recalls
- None
- Predicates
- 0
14 later devices descend from it, 2 citing it directly.
- This deviceK841153 Adaptor HR-3000 ReuseColorado Medical, Inc. · 1984
- Descendant · cites it directly · 12 of its ownK010131 PHD Personal Hemodialysis Instrument-1M101, PHD Water Pre-Treatment…Aksys, Ltd. · 2002 · Recalled
- Descendant · 2 generations on · 5 of its ownK112314 Nephros Olpur H2H Hemodiafiltration (HDF) Module and Olpur MD 220…Nephros, Inc. · 2012
- Descendant · 2 generations on · 5 of its ownK043436 Nxstage Dialysate Preparation Module, Model NX0269Nxstage Medical, Inc. · 2005
- Descendant · 3 generations on · 3 of its ownK060296 Nxstage Dialysate Preparation ModuleNxstage Medical, Inc. · 2006
- Descendant · 2 generations on · 2 of its ownK231534 5008X Hemodialysis SystemFresenius Medical Care · 2024 · Recalled
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K010131PHD Personal Hemodialysis Instrument-1M101, PHD Water Pre-Treatment Kit-1W605,PHD Hard…Aksys, Ltd. · 2002 · cites it directly12descendants
- K112314Nephros Olpur H2H Hemodiafiltration (HDF) Module and Olpur MD 220 HemodiafilterNephros, Inc. · 2012 · 2 generations on5descendants
- K043436Nxstage Dialysate Preparation Module, Model NX0269Nxstage Medical, Inc. · 2005 · 2 generations on5descendants
- K060296Nxstage Dialysate Preparation ModuleNxstage Medical, Inc. · 2006 · 3 generations on3descendants
- K2315345008X Hemodialysis SystemFresenius Medical Care · 2024 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K841153 | Adaptor HR-3000 Reuse | Colorado Medical, Inc. | 1984 | — |
| +1 | K010131 | PHD Personal Hemodialysis Instrument-1M101, PHD Water Pre-Treatment… | Aksys, Ltd. | 2002 | 1 |
| +2 | K112314 | Nephros Olpur H2H Hemodiafiltration (HDF) Module and Olpur MD 220 Hemodiafilter | Nephros, Inc. | 2012 | — |
| +2 | K043436 | Nxstage Dialysate Preparation Module, Model NX0269 | Nxstage Medical, Inc. | 2005 | — |
| +3 | K060296 | Nxstage Dialysate Preparation Module | Nxstage Medical, Inc. | 2006 | — |
| +2 | K231534 | 5008X Hemodialysis System | Fresenius Medical Care | 2024 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LIF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (14)
See all 142 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K010131 (Aksys, Ltd., 2002) has gone furthest, with 12 descendants of its own.
How does its category compare?
All LIF devicesLIF Dialyzer Reprocessing System: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LIF
1in 2010
2026 to Oct 25, outlined.
Median 510(k) review, days · LIF
Too few LIF 510(k)s in any year since 2007 to give a median.
Recalls per year · LIF
1in 2009
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LIF
1in 2017
MAUDE reports naming product code LIF, 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 | 0 | — | 0 | 3 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 1 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K841153 · printed Nov 6, 2026
Cite this page
510(k) Report. “K841153: Adaptor HR-3000 Reuse.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K841153
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026