510(k) · Cleared
ClearedHDM97
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ibp Instruments GmbH · FIZ Meter, Conductivity, Non-Remote
Cleared on May 22, 2002 as substantially equivalent to K992431 (Automata Instrumentation, Inc., 1999) after a 63-day review. Its family tree reaches back 1 generation to 1999. 2 later devices descend from it.
- Decided
- May 22, 2002
- Review
- 63 days
- Class
- Class II
- Product code
- FIZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K992431 (1999). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK992431 Neo-2 MeterAutomata Instrumentation, Inc. · 1999
- This deviceK020908 HDM97Ibp Instruments GmbH · 2002
- Descendant · cites it directly · 0 of its ownK201765 SmartHDM-510 SystemMesa Laboratories, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK043031 Serim Dialysate Monitor Test StripSerim Research Corp. · 2005
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K992431 | Neo-2 Meter | Automata Instrumentation, Inc. | 1999 | — |
| 0 (this device) | K020908 | HDM97 | Ibp Instruments GmbH | 2002 | — |
| +1 | K201765 | SmartHDM-510 System | Mesa Laboratories, Inc. | 2020 | — |
| +1 | K043031 | Serim Dialysate Monitor Test Strip | Serim Research Corp. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2020 | 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.
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? (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 |
|---|---|---|---|
| * | K992431 | Neo-2 MeterSummary page 2…tmann K6209058 nm@@ HDM97 - Premarket Notification 510(k) Summery Page : 2 of : 3 Substantial Equivalence Predicate Device Neo2 meter - 510(k) Number: K992431 Automata Instrumentation, Inc. 7830 East Redfield Road #12 Scottsdale, Arizona 85260 USA Description of the device The HDM97 w… | 1999 |
What descends from it? (2)
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?
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 HDM97 may be used by hemodialysis personnel to test the conductivity, temperature, pressure and pH of the dialysate solution used with hemodialysis delivering systems.
The HDM97 may also be used to test the conductivity/temperature and pH of acid and sodium bicarbonate dialysate concentrates and water used in hemodialysis applications.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K020908 · printed Nov 4, 2026
Cite this page
510(k) Report. “K020908: HDM97.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K020908
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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