510(k) · Cleared
ClearedRenalin Cold Sterilant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Minntech Corp. · LRJ Disinfectant, Medical Devices
Cleared on Jan 9, 1989 after a 202-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
- Jan 9, 1989
- Review
- 202 days
- Class
- Class I
- Product code
- LRJ
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK882564 Renalin Cold SterilantMinntech Corp. · 1989
- Descendant · cites it directly · 4 of its ownK962959 Peracidin Dialyzer Reprocessing ConcentrateHdc Medical, Inc. · 1998
- Descendant · 2 generations on · 3 of its ownK093641 TANGO3 Water Storage Tank with Ozone Disinfection SystemTango3, LLC · 2010 · Recalled
- Descendant · 3 generations on · 0 of its ownK140984 TANGO3 Water Storage Tank with Ozone Disinfection SystemTango3, LLC · 2015
- Descendant · 3 generations on · 0 of its ownK141213 Ameriwater Ozone Disinfection SystemAmeriwater · 2014
- Descendant · 3 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- K962959Peracidin Dialyzer Reprocessing ConcentrateHdc Medical, Inc. · 1998 · cites it directly4descendants
- K093641TANGO3 Water Storage Tank with Ozone Disinfection SystemTango3, LLC · 2010 · 2 generations on3descendants
- K140984TANGO3 Water Storage Tank with Ozone Disinfection SystemTango3, LLC · 2015 · 3 generations on0descendants
- K141213Ameriwater Ozone Disinfection SystemAmeriwater · 2014 · 3 generations on0descendants
- K142285AmeriWater Heatsan, 3-phase, 208v, 60hz, AmeriWater Heatsan, 3-phase, 460V, 60hz…Ameriwater · 2014 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K882564 | Renalin Cold Sterilant | Minntech Corp. | 1989 | — |
| +1 | K962959 | Peracidin Dialyzer Reprocessing Concentrate | Hdc Medical, Inc. | 1998 | — |
| +2 | K093641 | TANGO3 Water Storage Tank with Ozone Disinfection System | Tango3, LLC | 2010 | 1 |
| +3 | K140984 | TANGO3 Water Storage Tank with Ozone Disinfection System | Tango3, LLC | 2015 | — |
| +3 | K141213 | Ameriwater Ozone Disinfection System | Ameriwater | 2014 | — |
| +3 | 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 |
|---|---|---|
| 1998 | 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 LRJ? 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)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K962959 | Peracidin Dialyzer Reprocessing Concentrate | 1998 | 4 |
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, K962959 (Hdc Medical, Inc., 1998) has gone furthest, with 4 descendants of its own.
How does its category compare?
All LRJ devicesLRJ Disinfectant, Medical Devices: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LRJ
FDA has decided no LRJ device since 2007.
Median 510(k) review, days · LRJ
Too few LRJ 510(k)s in any year since 2007 to give a median.
Recalls per year · LRJ
4so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LRJ
70in 2025
MAUDE reports naming product code LRJ, 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 | 126 |
| 2008 | 0 | — | 0 | 72 |
| 2009 | 0 | — | 1 | 39 |
| 2010 | 0 | — | 0 | 18 |
| 2011 | 0 | — | 0 | 40 |
| 2012 | 0 | — | 0 | 37 |
| 2013 | 0 | — | 1 | 31 |
| 2014 | 0 | — | 0 | 18 |
| 2015 | 0 | — | 0 | 15 |
| 2016 | 0 | — | 0 | 13 |
| 2017 | 0 | — | 0 | 6 |
| 2018 | 0 | — | 0 | 15 |
| 2019 | 0 | — | 0 | 12 |
| 2020 | 0 | — | 0 | 73 |
| 2021 | 0 | — | 1 | 497 |
| 2022 | 0 | — | 0 | 171 |
| 2023 | 0 | — | 0 | 95 |
| 2024 | 0 | — | 0 | 116 |
| 2025 | 0 | — | 0 | 70 |
| 2026 | 0 | — | 4 | — |
https://510kreport.com/device/K882564 · printed Nov 6, 2026
Cite this page
510(k) Report. “K882564: Renalin Cold Sterilant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K882564
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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