510(k) · Cleared
ClearedCentra View Device Link System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Icu Datasystems, Inc. · MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Cleared on Oct 27, 2003 after a 13-day review. The FDA summary names no predicate by number. 21 later devices descend from it.
- Decided
- Oct 27, 2003
- Review
- 13 days
- Class
- Class II
- Product code
- MWI
- Recalls
- None
- Predicates
- 0
21 later devices descend from it, 2 citing it directly.
- This deviceK033283 Centra View Device Link SystemIcu Datasystems, Inc. · 2003
- Descendant · cites it directly · 19 of its ownK093422 Vital Sync Model 5000 SeriesSomanetics Corp. · 2010
- Descendant · 2 generations on · 18 of its ownK142732 T3 SoftwareEtiometry, Inc. · 2015
- Descendant · 3 generations on · 17 of its ownK151715 T3 SoftwareEtiometry, Inc. · 2015
- Descendant · 3 generations on · 16 of its ownK152258 T3 SoftwareEtiometry, Inc. · 2016
- Descendant · 4 generations on · 15 of its ownK163065 T3 SoftwareEtiometry, Inc. · 2017
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K093422Vital Sync Model 5000 SeriesSomanetics Corp. · 2010 · cites it directly19descendants
- K142732T3 SoftwareEtiometry, Inc. · 2015 · 2 generations on18descendants
- K151715T3 SoftwareEtiometry, Inc. · 2015 · 3 generations on17descendants
- K152258T3 SoftwareEtiometry, Inc. · 2016 · 3 generations on16descendants
- K163065T3 SoftwareEtiometry, Inc. · 2017 · 4 generations on15descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K033283 | Centra View Device Link System | Icu Datasystems, Inc. | 2003 | — |
| +1 | K093422 | Vital Sync Model 5000 Series | Somanetics Corp. | 2010 | — |
| +2 | K142732 | T3 Software | Etiometry, Inc. | 2015 | — |
| +3 | K151715 | T3 Software | Etiometry, Inc. | 2015 | — |
| +3 | K152258 | T3 Software | Etiometry, Inc. | 2016 | — |
| +4 | K163065 | T3 Software | Etiometry, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 4 | 0 |
| 2024 | 2 | 0 |
| 2025 | 4 | 0 |
| 2026 | 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 MWI? 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 MWI device
- #1 K230457 Empatica Health Monitoring Platform…score 28.0 · 39 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (21)
See all 212 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, K093422 (Somanetics Corp., 2010) has gone furthest, with 19 descendants of its own.
How does its category compare?
All MWI devicesMWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MWI
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MWI
247in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MWI
9so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MWI
182in 2025
MAUDE reports naming product code MWI, 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 | 9 | 42 | 1 | 3 |
| 2008 | 9 | 49 | 1 | 3 |
| 2009 | 6 | 112 | 2 | 20 |
| 2010 | 17 | 58 | 2 | 17 |
| 2011 | 11 | 78 | 3 | 16 |
| 2012 | 13 | 104 | 5 | 31 |
| 2013 | 20 | 85 | 3 | 42 |
| 2014 | 16 | 148 | 6 | 30 |
| 2015 | 19 | 127 | 1 | 31 |
| 2016 | 12 | 165 | 0 | 51 |
| 2017 | 13 | 205 | 2 | 85 |
| 2018 | 11 | 217 | 0 | 158 |
| 2019 | 14 | 255 | 4 | 169 |
| 2020 | 8 | 138 | 0 | 110 |
| 2021 | 9 | 161 | 0 | 188 |
| 2022 | 5 | 231 | 2 | 168 |
| 2023 | 8 | 250 | 0 | 179 |
| 2024 | 10 | 202 | 5 | 120 |
| 2025 | 4 | 247 | 0 | 182 |
| 2026 | 6 | 239 | 9 | — |
What is it indicated for?
The CentraView patient monitor is intended for monitoring, and recording of multiple physiological parameters. The device is indicated for use in health care facilities by health care professionals whenever there is a need for monitoring of physiological parameters of adult, neonatal, and @attic patients. CentraView is indicated for use in data collection and clinical information management through cable connections with independent bedside devices.…
Read the full statement (134 words)
The CentraView patient monitor is intended for monitoring, and recording of multiple physiological parameters. The device is indicated for use in health care facilities by health care professionals whenever there is a need for monitoring of physiological parameters of adult, neonatal, and @attic patients. CentraView is indicated for use in data collection and clinical information management through cable connections with independent bedside devices. CentmView is not intended for monitoring purposes, nor is it intended to control any of the independent bedside devices it is connected to.
The CentraView System:
Is intended for use on neonatal, @atric and adult patients.
Is intended for use in critical care environments by trained healthcare providers.
Does not require direct patient contact.
Is a prescription device which restricts its sale andor use except by the order of a physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033283 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033283: Centra View Device Link System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033283
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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