510(k) · Cleared
ClearedCosmos System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spacelabs Medical, Inc. · DSI Detector And Alarm, Arrhythmia
Cleared on Aug 21, 2002 after a 345-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Aug 21, 2002
- Review
- 345 days
- Class
- Class II
- Product code
- DSI
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK013046 Cosmos SystemSpacelabs Medical, Inc. · 2002
- Descendant · cites it directly · 3 of its ownK062095 Mcare 300 Vital Signs Monitor, Model 91220Spacelabs Medical, Inc. · 2006
- Descendant · 2 generations on · 1 of its ownK100217 Lucon M-Series Patient Monitor, Models M20 and M30Mediana Co., Ltd. · 2010
- Descendant · 2 generations on · 0 of its ownK112190 Patient MonitorMediana Co., Ltd. · 2011
- Descendant · 2 generations on · 0 of its ownK082045 Modification to Mcare 300 Vital Signs Monitor, Model 91220Spacelabs Medical, Inc. · 2008 · Recalled
- Descendant · cites it directly · 0 of its ownK031124 Polaris 95000-a Bedside/Transport MonitorDatex-Ohmeda, Inc. · 2003 · Recalled
Most influential descendants
Showing 5 of 5 · See all- K062095Mcare 300 Vital Signs Monitor, Model 91220Spacelabs Medical, Inc. · 2006 · cites it directly3descendants
- K100217Lucon M-Series Patient Monitor, Models M20 and M30Mediana Co., Ltd. · 2010 · 2 generations on1descendant
- K112190Patient MonitorMediana Co., Ltd. · 2011 · 2 generations on0descendants
- K082045Modification to Mcare 300 Vital Signs Monitor, Model 91220Spacelabs Medical, Inc. · 2008 · 2 generations on0descendants
- K031124Polaris 95000-a Bedside/Transport MonitorDatex-Ohmeda, Inc. · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K013046 | Cosmos System | Spacelabs Medical, Inc. | 2002 | — |
| +1 | K062095 | Mcare 300 Vital Signs Monitor, Model 91220 | Spacelabs Medical, Inc. | 2006 | — |
| +2 | K100217 | Lucon M-Series Patient Monitor, Models M20 and M30 | Mediana Co., Ltd. | 2010 | — |
| +2 | K112190 | Patient Monitor | Mediana Co., Ltd. | 2011 | — |
| +2 | K082045 | Modification to Mcare 300 Vital Signs Monitor, Model 91220 | Spacelabs Medical, Inc. | 2008 | 1 |
| +1 | K031124 | Polaris 95000-a Bedside/Transport Monitor | Datex-Ohmeda, Inc. | 2003 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 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 DSI? 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 DSI device
- #1 K243349 BodyGuardian Remote Monitoring System (BGRMS…score 13.1 · 9 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? (5)
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, K062095 (Spacelabs Medical, Inc., 2006) has gone furthest, with 3 descendants of its own.
How does its category compare?
All DSI devicesDSI Detector And Alarm, Arrhythmia: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DSI
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DSI
243in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DSI
18in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DSI
712in 2025
MAUDE reports naming product code DSI, 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 | 7 | 151 | 4 | 64 |
| 2008 | 5 | 70 | 8 | 156 |
| 2009 | 6 | 73 | 3 | 279 |
| 2010 | 6 | 111 | 5 | 823 |
| 2011 | 6 | 114 | 3 | 793 |
| 2012 | 3 | 113 | 1 | 766 |
| 2013 | 1 | — | 0 | 795 |
| 2014 | 4 | 200 | 0 | 1,000 |
| 2015 | 9 | 127 | 0 | 1,645 |
| 2016 | 6 | 224 | 0 | 4,352 |
| 2017 | 0 | — | 0 | 3,594 |
| 2018 | 2 | — | 1 | 3,648 |
| 2019 | 3 | 243 | 4 | 3,485 |
| 2020 | 2 | — | 2 | 3,084 |
| 2021 | 0 | — | 0 | 3,092 |
| 2022 | 0 | — | 1 | 1,638 |
| 2023 | 2 | — | 2 | 1,616 |
| 2024 | 1 | — | 0 | 1,320 |
| 2025 | 1 | — | 18 | 712 |
| 2026 | 1 | — | 1 | — |
https://510kreport.com/device/K013046 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013046: Cosmos System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013046
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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