510(k) · Cleared
ClearedAmeriWater Heatsan, 3-phase, 208v, 60hz, AmeriWater Heatsan, 3-phase, 460V, 60hz, Ameriwater Heatsan, 3-phase, 575v, 60hz
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ameriwater · FIP Subsystem, Water Purification
Cleared on Dec 1, 2014 as substantially equivalent to K093641 (Tango3, LLC, 2010) after a 105-day review. Its family tree reaches back 3 generations to 1989.
- Decided
- Dec 1, 2014
- Review
- 105 days
- Class
- Class II
- Product code
- FIP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K882564 (1989). 8 ancestors in all, the oldest K830575 (1983). No later device cites it as a predicate yet.
- Root · 3 generations backK882564 Renalin Cold SterilantMinntech Corp. · 1989
- 2 generations backK962959 Peracidin Dialyzer Reprocessing ConcentrateHdc Medical, Inc. · 1998
- 1 generation backK093641 TANGO3 Water Storage Tank with Ozone Disinfection SystemTango3, LLC · 2010 · Recalled
- This deviceK142285 AmeriWater Heatsan, 3-phase, 208v, 60hz, AmeriWater Heatsan…Ameriwater · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K882564 | Renalin Cold Sterilant | Minntech Corp. | 1989 | — |
| −2 | K962959 | Peracidin Dialyzer Reprocessing Concentrate | Hdc Medical, Inc. | 1998 | — |
| −1 | K093641 | TANGO3 Water Storage Tank with Ozone Disinfection System | Tango3, LLC | 2010 | 1 |
| 0 (this device) | K142285 | AmeriWater Heatsan, 3-phase, 208v, 60hz, AmeriWater Heatsan, 3-phase, 460V… | Ameriwater | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1989 | 1 | 0 |
| 1994 | 1 | 0 |
| 1998 | 1 | 0 |
| 2005 | 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 FIP? 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 FIP device
- #1 K251851 DIASAFEplusUS (F00013010)score 14.1 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K093641 | TANGO3 Water Storage Tank with Ozone Disinfection SystemSummary page 4…r §876.5665 Panel: Gastroenterology Product Code: FIP Equivalent Device: K093641, TANGO3 Ozone System Device Description: The AmeriWater Heatsan is intended for use in hospitals, clinics, or dialysis cen… | 2010 |
| † | K974899 | Gambro Central Water Treatment System CWP 100 - Wro H | 1998 |
| † | K924695 | Aseptech Portable RO+ System | 1995 |
| † | K991519 | Ameriwater Purification System for Hemodialysis | 2000 |
| † | K111740 | Ameriwater Mro Portable Reverse Osmosis System - Single Patient, 1 to 3 Station | 2011 |
| † | K051031 | Ameriwater Solution Mix and Distribution System for Hemodialysis | 2006 |
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 25 years and passes through 4 companies; a new generation was cleared every 9.4 years on median.
- 2 of the 8 ancestors have a recall of any class.
- 2 other devices also cite its predicate K093641.
How does its category compare?
All FIP devicesFIP Subsystem, Water Purification: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · FIP
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FIP
88in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FIP
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FIP
77in 2025
MAUDE reports naming product code FIP, 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 | 1 |
| 2008 | 3 | 202 | 0 | 5 |
| 2009 | 3 | 167 | 0 | 0 |
| 2010 | 2 | — | 0 | 12 |
| 2011 | 4 | 116 | 0 | 4 |
| 2012 | 2 | — | 0 | 4 |
| 2013 | 4 | 125 | 0 | 41 |
| 2014 | 4 | 126 | 0 | 34 |
| 2015 | 2 | — | 0 | 12 |
| 2016 | 2 | — | 0 | 3 |
| 2017 | 1 | — | 0 | 6 |
| 2018 | 1 | — | 0 | 3 |
| 2019 | 2 | — | 0 | 13 |
| 2020 | 1 | — | 1 | 12 |
| 2021 | 1 | — | 0 | 35 |
| 2022 | 1 | — | 0 | 57 |
| 2023 | 3 | 69 | 0 | 140 |
| 2024 | 1 | — | 0 | 174 |
| 2025 | 4 | 88 | 0 | 77 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The AmeriWater Heatsan is an optional accessory for water treatment systems intended for use in hemodialysis applications. The Heatsan is designed to heat water received from the water purification system, and circulate the heated water around the distribution loop at a controlled sanitizing temperature (minimum temperature of 185°F) for a programmed length of time (minimum hold time of 2 hours) to provide heat disinfection of the water distribution loop. The AmeriWater Heatsan is intended for use in hospitals, clinics, or dialysis centers to provide heat disinfection resulting in total viable microbial counts below 50 CFU/ml.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142285 · printed Nov 5, 2026
Cite this page
510(k) Report. “K142285: AmeriWater Heatsan, 3-phase, 208v, 60hz, AmeriWater Heatsan, 3-phase, 460V, 60hz, Ameriwater Heatsan, 3-phase, 575v, 60hz.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K142285
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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