510(k) · Cleared
Cleared90XL Instrumentation 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 May 5, 2005 after a 35-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- May 5, 2005
- Review
- 35 days
- Class
- Class II
- Product code
- FIZ
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK050812 90XL Instrumentation SystemMesa Laboratories, Inc. · 2005
- Descendant · cites it directly · 0 of its ownK201765 SmartHDM-510 SystemMesa Laboratories, Inc. · 2020
Most influential descendants
Showing 1 of 1 · See all- K201765SmartHDM-510 SystemMesa Laboratories, Inc. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K050812 | 90XL Instrumentation System | Mesa Laboratories, Inc. | 2005 | — |
| +1 | K201765 | SmartHDM-510 System | Mesa Laboratories, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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.
Top candidate predicates for a new FIZ device
- #1 K201765 SmartHDM-510 Systemscore 0.3 · 2 generations · no Class I recall
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K201765 | SmartHDM-510 System | 2020 | 0 |
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, K201765 (Mesa Laboratories, Inc., 2020) has gone furthest, with 0 descendants of its own.
How does its category compare?
All FIZ devicesFIZ Meter, Conductivity, Non-Remote: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 90XL Dialysis Meter is intended for use by hemodialysis professionals to measure the conductivity, temperature, pH, and pressure of the dialysate solution associated with hemodialysis delivery systems. Water purification specialists may also use the 90XL instrumentation system to verify proper characteristics of the water used in hemodialysis. These parameters are key indicators of system performance that require periodic monitoring and adjusting to maintain safe and effective hemodialysis systems.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K050812 · printed Nov 4, 2026
Cite this page
510(k) Report. “K050812: 90XL Instrumentation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K050812
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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