510(k) · Cleared
ClearedRenalin (Tentative
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Renal Systems, Inc. · LIF Dialyzer Reprocessing System
Cleared on Mar 31, 1983 after a 36-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Mar 31, 1983
- Review
- 36 days
- Class
- Class II
- Product code
- LIF
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK830575 Renalin (TentativeRenal Systems, Inc. · 1983
- Descendant · cites it directly · 4 of its ownK043207 Ozone GeneratorGe Infrastructure Water & Process Technologies · 2005
- Descendant · cites it directly · 3 of its ownK093641 TANGO3 Water Storage Tank with Ozone Disinfection SystemTango3, LLC · 2010 · Recalled
- Descendant · 2 generations on · 0 of its ownK140984 TANGO3 Water Storage Tank with Ozone Disinfection SystemTango3, LLC · 2015
- Descendant · 2 generations on · 0 of its ownK141213 Ameriwater Ozone Disinfection SystemAmeriwater · 2014
- Descendant · 2 generations on · 0 of its ownK142285 AmeriWater Heatsan, 3-phase, 208v, 60hz, AmeriWater Heatsan…Ameriwater · 2014
Most influential descendants
Showing 5 of 5 · See all- K043207Ozone GeneratorGe Infrastructure Water & Process Technologies · 2005 · cites it directly4descendants
- K093641TANGO3 Water Storage Tank with Ozone Disinfection SystemTango3, LLC · 2010 · cites it directly3descendants
- K140984TANGO3 Water Storage Tank with Ozone Disinfection SystemTango3, LLC · 2015 · 2 generations on0descendants
- K141213Ameriwater Ozone Disinfection SystemAmeriwater · 2014 · 2 generations on0descendants
- K142285AmeriWater Heatsan, 3-phase, 208v, 60hz, AmeriWater Heatsan, 3-phase, 460V, 60hz…Ameriwater · 2014 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K830575 | Renalin (Tentative | Renal Systems, Inc. | 1983 | — |
| +1 | K043207 | Ozone Generator | Ge Infrastructure Water & Process Technologies | 2005 | — |
| +1 | K093641 | TANGO3 Water Storage Tank with Ozone Disinfection System | Tango3, LLC | 2010 | 1 |
| +2 | K140984 | TANGO3 Water Storage Tank with Ozone Disinfection System | Tango3, LLC | 2015 | — |
| +2 | K141213 | Ameriwater Ozone Disinfection System | Ameriwater | 2014 | — |
| +2 | K142285 | AmeriWater Heatsan, 3-phase, 208v, 60hz, AmeriWater Heatsan, 3-phase, 460V… | Ameriwater | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2010 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 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? (5)
2 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, K043207 (Ge Infrastructure Water & Process Technologies, 2005) has gone furthest, with 4 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/K830575 · printed Nov 6, 2026
Cite this page
510(k) Report. “K830575: Renalin (Tentative.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K830575
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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