510(k) · Cleared
ClearedNeo-2 Meter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Automata Instrumentation, Inc. · FIZ Meter, Conductivity, Non-Remote
Cleared on Oct 13, 1999 after an 84-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 4 later devices descend from it.
- Decided
- Oct 13, 1999
- Review
- 84 days
- Class
- Class II
- Product code
- FIZ
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK992431 Neo-2 MeterAutomata Instrumentation, Inc. · 1999
- Descendant · cites it directly · 2 of its ownK020908 HDM97Ibp Instruments GmbH · 2002
- Descendant · cites it directly · 1 of its ownK020909 HDM99Ibp Instruments GmbH · 2002
- Descendant · 2 generations on · 0 of its ownK201765 SmartHDM-510 SystemMesa Laboratories, Inc. · 2020
- Descendant · 2 generations on · 0 of its ownK043031 Serim Dialysate Monitor Test StripSerim Research Corp. · 2005
Most influential descendants
Showing 4 of 4 · See all- K020908HDM97Ibp Instruments GmbH · 2002 · cites it directly2descendants
- K020909HDM99Ibp Instruments GmbH · 2002 · cites it directly1descendant
- K201765SmartHDM-510 SystemMesa Laboratories, Inc. · 2020 · 2 generations on0descendants
- K043031Serim Dialysate Monitor Test StripSerim Research Corp. · 2005 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K992431 | Neo-2 Meter | Automata Instrumentation, Inc. | 1999 | — |
| +1 | K020908 | HDM97 | Ibp Instruments GmbH | 2002 | — |
| +1 | K020909 | HDM99 | Ibp Instruments GmbH | 2002 | — |
| +2 | K201765 | SmartHDM-510 System | Mesa Laboratories, Inc. | 2020 | — |
| +2 | K043031 | Serim Dialysate Monitor Test Strip | Serim Research Corp. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2005 | 1 | 0 |
| 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 0.2 · 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? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K020908 (Ibp Instruments GmbH, 2002) has gone furthest, with 2 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 NEO-2 Meter may be used by hemodialysis personnel to test conductivity, temperature, pressure, and pH of the dialysate solution used with hemodialysis delivery systems. The NEO-2 Meter may also be used to test the conductivity/temperature and pH of acid and sodium bicarbonate dialysate concentrates and water used in hemodillysis applications.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K992431 · printed Nov 6, 2026
Cite this page
510(k) Report. “K992431: Neo-2 Meter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992431
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