510(k) · Cleared
ClearedAmeriwater Alarm Panel - Base Model and Remote, Base Model & Remote with Conductivity, Base Model & Remote with Resistiv
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ameriwater · FIP Subsystem, Water Purification
Cleared on Sep 17, 2012 as substantially equivalent to K991519 (Ameriwater, 2000) after a 166-day review. Its family tree reaches back 2 generations to 1990.
- Decided
- Sep 17, 2012
- Review
- 166 days
- Class
- Class II
- Product code
- FIP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K894300 (1990). No later device cites it as a predicate yet.
- Root · 2 generations backK894300 Submersible Reverse Osmosis Water Purification SysU.S. Filter/Continental Water Systems · 1990
- 1 generation backK991519 Ameriwater Purification System for HemodialysisAmeriwater · 2000
- This deviceK121022 Ameriwater Alarm Panel - Base Model and Remote, Base Model & Remote…Ameriwater · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K894300 | Submersible Reverse Osmosis Water Purification Sys | U.S. Filter/Continental Water Systems | 1990 | — |
| −1 | K991519 | Ameriwater Purification System for Hemodialysis | Ameriwater | 2000 | — |
| 0 (this device) | K121022 | Ameriwater Alarm Panel - Base Model and Remote, Base Model & Remote with… | Ameriwater | 2012 | — |
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 14.0 · 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 |
|---|---|---|---|
| * | K991519 | Ameriwater Purification System for HemodialysisSummary page 1…76.5665 Panel: Gastroenterology Product Code: FIP Equivalent Device: K991 519, AmeniWater Water Purification System Device Description: The AmeniWater Alarm Panel is designed to let technicians and… | 2000 |
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 22 years and passes through 2 companies; a new generation was cleared every 12.4 years on median.
- None of the 2 ancestors has a recall.
- 9 other devices also cite its predicate K991519.
How does its category compare?
All FIP devicesFIP Subsystem, Water Purification: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 AmerWater Alarm Panel is intended for use in hospitals and dialysis clinics as an optional component in the AmeniWater Water Purification System (WPS) for hemodialysis applications. The AmeniWater Alarm Panel is intended to notify the operator of conditions that exist with the Water Purification System requiring the operators attention. The AmeniWater WPS is intended to remove organic and inorganic substances and microbial contaminants from water.…
Read the full statement (428 words)
The AmerWater Alarm Panel is intended for use in hospitals and dialysis clinics as an optional component in the AmeniWater Water Purification System (WPS) for hemodialysis applications. The AmeniWater Alarm Panel is intended to notify the operator of conditions that exist with the Water Purification System requiring the operators attention. The AmeniWater WPS is intended to remove organic and inorganic substances and microbial contaminants from water. The Purified (or treated) water will then be used to prepare and dilute dialysate concentrate to form dialysate and/or rinse dialyzers for multiple use and/or to prepare dilute solutions for reprocessing procedures in multiple-use dialyzers. The Alarm Panels are designed to meet current AAMI and Federal (U.S.) standards.
Model 00850250 -Base Model & Remote Panel. This model includes RIO Alarm, Low Storage Tank, and Low Bicarb. there are also 5 additional dry contact inputs. When one of these receives a closure from the external source, such as a low tank level in a chemical feed system, the LCD will indicate an alarm and display the input number in the alarm display. The alarm panel also includes an Alarm Silence function.
The Remote is installed at the Nurse's Station on the treatment floor. It has a set of lights and audible alarm that corresponds to what is indicated on the main panel in the water room however there is no "Alarm Silence" available on the Remote Panel. To silence the alarm, it will require the users attention in the water room.
Model 00850251 - Base Model & Remote with Conductivity. This model includes all of the features of the base model with the addition of a conductivity sensor and high conductivity alarm. The Alarm Panel can be used to power solenoid valves to divedt the water flow to the drain when the conductivity is above the set-point.
Model 00850252 - Base Model & Remote with Resistivity and Dump Valve. This model includes all of the features of the base model with the addition of a resistivity sensor and low resistivity alarm with dump valve. The Alarm Panel can be used to power solenoid valves to divedt the water flow to the drain when the resistivity is below the set-point. A solenoid valve (dump valve) is included with this model to divert water to drain during a low resistivity alarm condition.
Model 00850253 - Base Model & Remote with Conductivity, Resistivity and Dump Valve. This model includes all of the features of the base model with the addition of a conductivity sensor, high conductivity alarm, resistivity sensor, and low resistivity alarm with dump valve.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121022 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121022: Ameriwater Alarm Panel - Base Model and Remote, Base Model & Remote with Conductivity, Base Model & Remote with Resistiv.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121022
Report an extraction error
Are you the manufacturer?
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