510(k) · Cleared
ClearedHach CM130 Chlorine Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hach Company · PSX Chlorine Meter
Cleared on Mar 30, 2017 as substantially equivalent to K983997 (Environmental Test Systems, Inc., 1999) after a 205-day review. Its family tree reaches back 1 generation to 1999.
- Decided
- Mar 30, 2017
- Review
- 205 days
- Class
- Class II
- Product code
- PSX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K983997 (1999). No later device cites it as a predicate yet.
- Root · 1 generation backK983997 Sterichek Total Chlorine Test KitEnvironmental Test Systems, Inc. · 1999
- This deviceK162471 Hach CM130 Chlorine Monitoring SystemHach Company · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K983997 | Sterichek Total Chlorine Test Kit | Environmental Test Systems, Inc. | 1999 | — |
| 0 (this device) | K162471 | Hach CM130 Chlorine Monitoring System | Hach Company | 2017 | — |
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 PSX? 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? (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 |
|---|---|---|---|
| * | K983997 | Sterichek Total Chlorine Test KitSummary page 4…0(k) Number Chemistry SteriChek® Chlorine K983997 Total Chlorine DPD Kit Measurements 7. Reference Devices: Sub-System… | 1999 |
| † | K974899 | Gambro Central Water Treatment System CWP 100 - Wro H | 1998 |
| † | K082182 | AP 34 Multi-Therapy Infusion Pump | 2008 |
| † | K093244 | Unique Temp Warming Blankets, Model 8001140XXX | 2010 |
| † | K100237 | Dialysate Meter, Model D-6 | 2010 |
| † | K121022 | Ameriwater Alarm Panel - Base Model and Remote, Base Model & Remote with Conductivity… | 2012 |
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?
- Its one ancestor has no recall.
How does its category compare?
All PSX devicesPSX Chlorine Meter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · PSX
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · PSX
Too few PSX 510(k)s in any year since 2007 to give a median.
Recalls per year · PSX
No recall names PSX since 2007.
Adverse event reports per year · PSX
No MAUDE report names PSX since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 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 | — |
What is it indicated for?
The Hach CM130 is an instrument that is intended for use by hemodialysis professionals to automatically monitor low levels of total chlorine (i.e. total chloramines plus free chlorine) in feed water used to prepare dialysate in hemodialysis systems.
The CM130 is a component of the complete water treatment system for hemodialysis and does not treat or alter the water used in dialysate. The CM130 instrument’s automated monitoring records total chlorine values in feed water at intervals between 5 and 20 minutes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162471 · printed Nov 4, 2026
Cite this page
510(k) Report. “K162471: Hach CM130 Chlorine Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K162471
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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