510(k) · Cleared
ClearedPhoenix XL Dialysate Meter
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 21, 2015 as substantially equivalent to K955298 (Automata Medical Instrumentation, Inc., 1996) after a 192-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Sep 21, 2015
- Review
- 192 days
- Class
- Class II
- Product code
- FIZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K955298 (1996). No later device cites it as a predicate yet.
- Root · 1 generation backK955298 Phoenix Dialysate MeterAutomata Medical Instrumentation, Inc. · 1996
- This deviceK150657 Phoenix XL Dialysate MeterMesa Laboratories, Inc. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K955298 | Phoenix Dialysate Meter | Automata Medical Instrumentation, Inc. | 1996 | — |
| 0 (this device) | K150657 | Phoenix XL Dialysate Meter | Mesa Laboratories, Inc. | 2015 | — |
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.
Top candidate predicates for a new FIZ device
- #1 K201765 SmartHDM-510 Systemscore 0.2 · 2 generations · no Class I recall
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 |
|---|---|---|---|
| * | K955298 | Phoenix Dialysate MeterSummary page 4…Product Code FIZ Predicate Phoenix Dialysate Meter Device(s): Mesa Laboratories Inc 510(k) Number K955298 Cleared February 29, 1996 Device This device is a hand-held battery powered, multi-test D… | 1996 |
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 FIZ devicesFIZ Meter, Conductivity, Non-Remote: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
This device is designed for use by hemodialysis professionals to verify the conductivity, temperature, and pH of solutions in the hemodialysis setting
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150657 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150657: Phoenix XL Dialysate Meter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150657
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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