510(k) · Cleared
ClearedModification to Computerized Catheterization Laboratory - Horizon 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 Jun 24, 1999 as substantially equivalent to K940415 (Mennen Medical, Inc., 1995) after a 30-day review. Its family tree reaches back 1 generation to 1995. 5 later devices descend from it.
- Decided
- Jun 24, 1999
- Review
- 30 days
- Class
- Class II
- Product code
- DXG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K940415 (1995). 5 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK940415 Horizon 9000 WSMennen Medical, Inc. · 1995
- This deviceK991775 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
- Descendant · 2 generations on · 0 of its ownK043564 Horizon Angio CathlabMennen Medical, Ltd. · 2005
Most influential descendants
Showing 5 of 5 · See all- 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
- K043564Horizon Angio CathlabMennen Medical, Ltd. · 2005 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K940415 | Horizon 9000 WS | Mennen Medical, Inc. | 1995 | — |
| 0 (this device) | 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 | — |
| +2 | K043564 | Horizon Angio Cathlab | Mennen Medical, Ltd. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 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 11.1 · 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? (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 |
|---|---|---|---|
| * | K940415 | Horizon 9000 WSSummary page 2…Classification: Class I Product code: 74 DXG Performance Standards None promulgated Predicate Devices Horizon 9000 WS — cleared for market by FDA on January 6, 1995 — K 940415 Date of preparation of Summary June 10, 1999 Device Description The HORIZON 9000 WS (Cathlab) is a state-of-the-art computeriz… | 1995 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K032997 | Modification to: Horizon 9000WS | 2003 | 4 |
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 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K991775 · printed Nov 4, 2026
Cite this page
510(k) Report. “K991775: Modification to Computerized Catheterization Laboratory - Horizon 9000 WS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991775
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