510(k) · Cleared
ClearedModification to: Horizon 9000WS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mennen Medical, Ltd. · DXG Computer, Diagnostic, Pre-Programmed, Single-Function
Cleared on Oct 15, 2003 as substantially equivalent to K940415 (Mennen Medical, Inc., 1995) and 1 other predicate after a 20-day review. Its family tree reaches back 2 generations to 1995. 4 later devices descend from it.
- Decided
- Oct 15, 2003
- Review
- 20 days
- Class
- Class II
- Product code
- DXG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K940415 (1995). 4 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK940415 Horizon 9000 WSMennen Medical, Inc. · 1995
- 1 generation backK991775 Modification to Computerized Catheterization Laboratory - Horizon…Mennen Medical, Inc. · 1999
- This deviceK032997 Modification to: Horizon 9000WSMennen Medical, Ltd. · 2003
- Descendant · cites it directly · 1 of its ownK081484 Horizon XvuMennen Medical, Ltd. · 2008
- Descendant · 2 generations on · 0 of its ownK091165 Horizon XvuMennen Medical, Ltd. · 2009
- Descendant · cites it directly · 0 of its ownK070254 Horizon SEMennen Medical, Ltd. · 2007
- Descendant · cites it directly · 0 of its ownK043564 Horizon Angio CathlabMennen Medical, Ltd. · 2005
Most influential descendants
Showing 4 of 4 · See all- K081484Horizon XvuMennen Medical, Ltd. · 2008 · cites it directly1descendant
- K091165Horizon XvuMennen Medical, Ltd. · 2009 · 2 generations on0descendants
- K070254Horizon SEMennen Medical, Ltd. · 2007 · cites it directly0descendants
- K043564Horizon Angio CathlabMennen Medical, Ltd. · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K940415 | Horizon 9000 WS | Mennen Medical, Inc. | 1995 | — |
| −1 | K991775 | Modification to Computerized Catheterization Laboratory - Horizon 9000 WS | Mennen Medical, Inc. | 1999 | — |
| 0 (this device) | K032997 | Modification to: Horizon 9000WS | Mennen Medical, Ltd. | 2003 | — |
| +1 | K081484 | Horizon Xvu | Mennen Medical, Ltd. | 2008 | — |
| +2 | K091165 | Horizon Xvu | Mennen Medical, Ltd. | 2009 | — |
| +1 | K070254 | Horizon SE | Mennen Medical, Ltd. | 2007 | — |
| +1 | K043564 | Horizon Angio Cathlab | Mennen Medical, Ltd. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 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 DXG? 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 DXG device
- #1 K253092 Argos Infinity (Rev. 1.0)score 11.2 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K940415 | Horizon 9000 WSSummary page 2…he data acquisition module of the Horizon 9000WS after modification, the subject of this Special 510(k). Predicate Device: Horizon 9000WS Cathlab with PFE - K940415 and K991775 Food and Drug Administration Device Modification - Horizon 9000WS Cathlab: Special 5 10(k) for new… | 1995 |
| * | K991775 | Modification to Computerized Catheterization Laboratory - Horizon 9000 WSSummary page 2…isition module of the Horizon 9000WS after modification, the subject of this Special 510(k). Predicate Device: Horizon 9000WS Cathlab with PFE - K940415 and K991775 Food and Drug Administration Device Modification - Horizon 9000WS Cathlab: Special 5 10(k) for new PFE (Patien… | 1999 |
What descends from it? (4)
3 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?
- The line of descent spans 8 years and passes through 2 companies; a new generation was cleared every 4.5 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K081484 (Mennen Medical, Ltd., 2008) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K940415.
How does its category compare?
All DXG devicesDXG Computer, Diagnostic, Pre-Programmed, Single-Function: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DXG
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXG
290in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXG
2in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXG
8in 2025
MAUDE reports naming product code DXG, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 1 | 43 |
| 2008 | 5 | 118 | 1 | 37 |
| 2009 | 0 | — | 6 | 8 |
| 2010 | 4 | 282 | 1 | 17 |
| 2011 | 3 | 104 | 0 | 7 |
| 2012 | 2 | — | 0 | 29 |
| 2013 | 3 | 236 | 0 | 23 |
| 2014 | 6 | 290 | 0 | 44 |
| 2015 | 1 | — | 0 | 34 |
| 2016 | 1 | — | 0 | 67 |
| 2017 | 1 | — | 0 | 62 |
| 2018 | 2 | — | 0 | 83 |
| 2019 | 2 | — | 0 | 81 |
| 2020 | 1 | — | 2 | 49 |
| 2021 | 1 | — | 0 | 29 |
| 2022 | 0 | — | 0 | 44 |
| 2023 | 1 | — | 0 | 12 |
| 2024 | 0 | — | 0 | 21 |
| 2025 | 1 | — | 0 | 8 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The HORIZON 9000 WS (Cathlab) is a state-of-the-art computerized laboratory, capable of acquiring and displaying essential patient data such as ECG/Heart Rate, invasive blood pressure, pulse oximetry, respiration, cardiac output and body temperature.
Heart rate, multi-lead ECG and BP waveforms from different heart sites are continuously presented on the Physiological Waveform Display. The hemodynamic data, waveform and numerical, can be stored, recorded, analyzed and presented in a variety of report formats.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032997 · printed Nov 4, 2026
Cite this page
510(k) Report. “K032997: Modification to: Horizon 9000WS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K032997
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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