510(k) · Cleared
ClearedHorizon Xvu
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mennen Medical, Ltd. · DQK Computer, Diagnostic, Programmable
Cleared on Jun 20, 2008 as substantially equivalent to K032997 (Mennen Medical, Ltd., 2003) after a 23-day review. Its family tree reaches back 3 generations to 1995. 1 later device descends from it.
- Decided
- Jun 20, 2008
- Review
- 23 days
- Class
- Class II
- Product code
- DQK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K940415 (1995). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK940415 Horizon 9000 WSMennen Medical, Inc. · 1995
- 2 generations backK991775 Modification to Computerized Catheterization Laboratory - Horizon…Mennen Medical, Inc. · 1999
- 1 generation backK032997 Modification to: Horizon 9000WSMennen Medical, Ltd. · 2003
- This deviceK081484 Horizon XvuMennen Medical, Ltd. · 2008
- Descendant · cites it directly · 0 of its ownK091165 Horizon XvuMennen Medical, Ltd. · 2009
Most influential descendants
Showing 1 of 1 · See all- K091165Horizon XvuMennen Medical, Ltd. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K940415 | Horizon 9000 WS | Mennen Medical, Inc. | 1995 | — |
| −2 | K991775 | Modification to Computerized Catheterization Laboratory - Horizon 9000 WS | Mennen Medical, Inc. | 1999 | — |
| −1 | K032997 | Modification to: Horizon 9000WS | Mennen Medical, Ltd. | 2003 | — |
| 0 (this device) | K081484 | Horizon Xvu | Mennen Medical, Ltd. | 2008 | — |
| +1 | K091165 | Horizon Xvu | Mennen Medical, Ltd. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 DQK? 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 DQK device
- #1 K213682 HemoSphere Advanced Monitor, HemoSphere…score 26.6 · 28 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 |
|---|---|---|---|
| * | K032997 | Modification to: Horizon 9000WSSummary page 1…cal to the Horizon SE Cathlab but with different graphic user interface. Horizon SE = The predicate device. The Horizon SE Cathlab was cleared for marketing by the FDA (K032997) Intended Use of the Horizon SE/Horizon XVu: The Horizon XVu is a state-of-the-art computerized laboratory, capable of acquirin… | 2003 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K091165 | Horizon Xvu | 2009 | 0 |
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 13 years and passes through 2 companies; a new generation was cleared every 4.5 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K091165 (Mennen Medical, Ltd., 2009) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K032997.
How does its category compare?
All DQK devicesDQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · DQK
23so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · DQK
95in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQK
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DQK
433in 2025
MAUDE reports naming product code DQK, 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 | 13 | 83 | 4 | 18 |
| 2008 | 4 | 70 | 1 | 34 |
| 2009 | 12 | 93 | 2 | 40 |
| 2010 | 9 | 64 | 3 | 49 |
| 2011 | 12 | 69 | 2 | 55 |
| 2012 | 7 | 74 | 3 | 129 |
| 2013 | 13 | 68 | 1 | 180 |
| 2014 | 9 | 90 | 4 | 115 |
| 2015 | 7 | 125 | 2 | 131 |
| 2016 | 15 | 190 | 0 | 340 |
| 2017 | 7 | 146 | 2 | 252 |
| 2018 | 14 | 150 | 6 | 261 |
| 2019 | 15 | 113 | 1 | 218 |
| 2020 | 16 | 123 | 1 | 215 |
| 2021 | 16 | 132 | 1 | 351 |
| 2022 | 19 | 136 | 2 | 319 |
| 2023 | 21 | 133 | 2 | 340 |
| 2024 | 13 | 100 | 24 | 557 |
| 2025 | 22 | 95 | 1 | 433 |
| 2026 | 23 | 151 | 2 | — |
What is it indicated for?
The Horizon XVu is a state-of-the-art computerized laboratory, capable of acquiring and displaying essential patient data such as ECG/Heart Rate, invasive blood pressures, pulse oximetry, respiration, cardiac output, body temperatures and EtCO2. 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/K081484 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081484: Horizon Xvu.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081484
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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