510(k) · Cleared
ClearedSmartHDM-510 System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mesa Laboratories, Inc. · FIZ Meter, Conductivity, Non-Remote
Cleared on Sep 2, 2020 as substantially equivalent to K020909 (Ibp Instruments GmbH, 2002) and 2 other predicates after a 65-day review. Its family tree reaches back 2 generations to 1999.
- Decided
- Sep 2, 2020
- Review
- 65 days
- Class
- Class II
- Product code
- FIZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K992431 (1999). 4 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K992431 | Neo-2 Meter | Automata Instrumentation, Inc. | 1999 | — |
| −1 | K020909 | HDM99 | Ibp Instruments GmbH | 2002 | — |
| 0 (this device) | K201765 | SmartHDM-510 System | Mesa Laboratories, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 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 FIZ? 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? (3)
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 |
|---|---|---|---|
| * | K020909 | HDM99Summary page 4…Device Class: 2 Regulation Number: 21 CFR 876.5540 Medical Specialty: Gastroenterology Predicate K020909 HDM99 (Dialysis Meters) primary device Devices K020908 HDM97 (Dialysis Meters) K050812 90XL… | 2002 |
| * | K020908 | HDM97Summary page 4…21 CFR 876.5540 Medical Specialty: Gastroenterology Predicate K020909 HDM99 (Dialysis Meters) primary device Devices K020908 HDM97 (Dialysis Meters) K050812 90XL Instrumentation System Devices Description The SmartHDM-510 System… | 2002 |
| * | K050812 | 90XL Instrumentation SystemSummary page 4…ty: Gastroenterology Predicate K020909 HDM99 (Dialysis Meters) primary device Devices K020908 HDM97 (Dialysis Meters) K050812 90XL Instrumentation System Devices Description The SmartHDM-510 System is designed for the installation and maintenance of he… | 2005 |
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 21 years and passes through 3 companies; a new generation was cleared every 18.3 years on median.
- None of the 4 ancestors has a recall.
How does its category compare?
All FIZ devicesFIZ Meter, Conductivity, Non-Remote: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · FIZ
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · FIZ
Too few FIZ 510(k)s in any year since 2007 to give a median.
Recalls per year · FIZ
No recall names FIZ since 2007.
Adverse event reports per year · FIZ
No MAUDE report names FIZ 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 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 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 SmartHDM-510 system may be used by hemodialysis personnel to test the conductivity, temperature, pressure, pH and flow of the dialysate solution used with hemodialysis delivering systems.
The SmartHDM-510 system may also be used to test the conductivity/temperature and pH of acid and sodium bicarbonate dialysate concentrates and water used in hemodialysis applications.
The intended use is limited to periodic use for installation and maintenance of hemodialysis delivering systems and does not include the daily monitoring of hemodialysis delivering systems prior to treatment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201765 · printed Nov 3, 2026
Cite this page
510(k) Report. “K201765: SmartHDM-510 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K201765
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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