510(k) · Cleared
ClearedCerner Careaware Ibus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cerner Corp. · DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Cleared on Nov 27, 2009 after a 53-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 7 later devices descend from it.
- Decided
- Nov 27, 2009
- Review
- 53 days
- Class
- Class II
- Product code
- DRG
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 1 citing it directly.
- This deviceK093134 Cerner Careaware IbusCerner Corp. · 2009
- Descendant · cites it directly · 6 of its ownK100133 Airstrip Remote Patient Monitoring (RPM) Remote Data Viewing…Airstrip Technologies, LP · 2010
- Descendant · 2 generations on · 5 of its ownK142106 Decisio Health Patient DashboardDecisio Health, Inc. · 2015
- Descendant · 3 generations on · 3 of its ownK213335 Capsule Surveillance SystemCapsule Surveillance Technologies, Sas /Capsule Tech, Inc. · 2022
- Descendant · 4 generations on · 0 of its ownK241958 WARD-CSS (v1.2.x)Ward 24/7 Aps · 2025
- Descendant · 4 generations on · 0 of its ownK240756 Aitrics-VCAitrics Co., Ltd. · 2024
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K100133Airstrip Remote Patient Monitoring (RPM) Remote Data Viewing Software, Version 3.1Airstrip Technologies, LP · 2010 · cites it directly6descendants
- K142106Decisio Health Patient DashboardDecisio Health, Inc. · 2015 · 2 generations on5descendants
- K213335Capsule Surveillance SystemCapsule Surveillance Technologies, Sas /Capsule Tech, Inc. · 2022 · 3 generations on3descendants
- K241958WARD-CSS (v1.2.x)Ward 24/7 Aps · 2025 · 4 generations on0descendants
- K240756Aitrics-VCAitrics Co., Ltd. · 2024 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K093134 | Cerner Careaware Ibus | Cerner Corp. | 2009 | — |
| +1 | K100133 | Airstrip Remote Patient Monitoring (RPM) Remote Data Viewing Software, Version… | Airstrip Technologies, LP | 2010 | — |
| +2 | K142106 | Decisio Health Patient Dashboard | Decisio Health, Inc. | 2015 | — |
| +3 | K213335 | Capsule Surveillance System | Capsule Surveillance Technologies, Sas /Capsule Tech, Inc. | 2022 | — |
| +4 | K241958 | WARD-CSS (v1.2.x) | Ward 24/7 Aps | 2025 | — |
| +4 | K240756 | Aitrics-VC | Aitrics Co., Ltd. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2015 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DRG? 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 DRG device
- #1 K223711 ANNE Onescore 20.8 · 11 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’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K100133 | Airstrip Remote Patient Monitoring (RPM) Remote Data Viewing Software, Version 3.1 | 2010 | 6 |
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, K100133 (Airstrip Technologies, LP, 2010) has gone furthest, with 6 descendants of its own.
How does its category compare?
All DRG devicesDRG Transmitters And Receivers, Physiological Signal, Radiofrequency: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · DRG
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DRG
127in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DRG
3in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DRG
52in 2025
MAUDE reports naming product code DRG, 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 | 6 | 63 | 3 | 14 |
| 2008 | 5 | 74 | 0 | 9 |
| 2009 | 13 | 94 | 0 | 5 |
| 2010 | 10 | 68 | 0 | 13 |
| 2011 | 9 | 104 | 0 | 12 |
| 2012 | 12 | 103 | 0 | 9 |
| 2013 | 13 | 146 | 0 | 13 |
| 2014 | 10 | 177 | 0 | 97 |
| 2015 | 2 | — | 0 | 131 |
| 2016 | 2 | — | 0 | 182 |
| 2017 | 7 | 98 | 0 | 484 |
| 2018 | 6 | 220 | 0 | 166 |
| 2019 | 5 | 122 | 0 | 70 |
| 2020 | 6 | 159 | 0 | 82 |
| 2021 | 2 | — | 0 | 107 |
| 2022 | 6 | 287 | 0 | 43 |
| 2023 | 4 | 212 | 0 | 19 |
| 2024 | 3 | 125 | 0 | 26 |
| 2025 | 3 | 127 | 0 | 52 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
Cerner iBus is a software application intended for use in the transportation, aggregation and derivation of data between medical devices and external systems used in a clinical setting for the purpose of automating data collection and clinical information management.
Cerner iBus is not intended to directly monitor, diagnose or treat patients or to be used in the prevention of a disease or condition, nor does Cerner iBus come into direct contact with patients.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K093134 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093134: Cerner Careaware Ibus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093134
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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