510(k) · Cleared
ClearedHorizon 9000 WS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mennen Medical, Inc. · DXG Computer, Diagnostic, Pre-Programmed, Single-Function
Cleared on Jan 6, 1995 after a 343-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.
- Decided
- Jan 6, 1995
- Review
- 343 days
- Class
- Class II
- Product code
- DXG
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 2 citing it directly.
- This deviceK940415 Horizon 9000 WSMennen Medical, Inc. · 1995
- Descendant · cites it directly · 5 of its ownK991775 Modification to Computerized Catheterization Laboratory - Horizon…Mennen Medical, Inc. · 1999
- Descendant · cites it directly · 4 of its ownK032997 Modification to: Horizon 9000WSMennen Medical, Ltd. · 2003
- Descendant · 2 generations on · 1 of its ownK081484 Horizon XvuMennen Medical, Ltd. · 2008
- Descendant · 3 generations on · 0 of its ownK091165 Horizon XvuMennen Medical, Ltd. · 2009
- Descendant · 2 generations on · 0 of its ownK070254 Horizon SEMennen Medical, Ltd. · 2007
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K991775Modification to Computerized Catheterization Laboratory - Horizon 9000 WSMennen Medical, Inc. · 1999 · cites it directly5descendants
- K032997Modification to: Horizon 9000WSMennen Medical, Ltd. · 2003 · cites it directly4descendants
- K081484Horizon XvuMennen Medical, Ltd. · 2008 · 2 generations on1descendant
- K091165Horizon XvuMennen Medical, Ltd. · 2009 · 3 generations on0descendants
- K070254Horizon SEMennen Medical, Ltd. · 2007 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K940415 | Horizon 9000 WS | Mennen Medical, Inc. | 1995 | — |
| +1 | K991775 | Modification to Computerized Catheterization Laboratory - Horizon 9000 WS | Mennen Medical, Inc. | 1999 | — |
| +1 | K032997 | Modification to: Horizon 9000WS | Mennen Medical, Ltd. | 2003 | — |
| +2 | K081484 | Horizon Xvu | Mennen Medical, Ltd. | 2008 | — |
| +3 | K091165 | Horizon Xvu | Mennen Medical, Ltd. | 2009 | — |
| +2 | K070254 | Horizon SE | Mennen Medical, Ltd. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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 11.1 · 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (6)
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, K991775 (Mennen Medical, Inc., 1999) has gone furthest, with 5 descendants of its own.
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 | — |
https://510kreport.com/device/K940415 · printed Nov 6, 2026
Cite this page
510(k) Report. “K940415: Horizon 9000 WS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K940415
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026