510(k) · Cleared
Recalled · 2010Brentwood PC-Ecg
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Brentwood Medical Products, Inc. · DSI Detector And Alarm, Arrhythmia
Cleared on Jan 22, 1997 after a 447-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 19 later devices descend from it. It has been recalled 3 times.
- Decided
- Jan 22, 1997
- Review
- 447 days
- Class
- Class II
- Product code
- DSI
- Recalls
- 3
- Predicates
- 0
19 later devices descend from it, 4 citing it directly.
- This deviceK955023 Brentwood PC-EcgBrentwood Medical Products, Inc. · 1997
- Descendant · cites it directly · 6 of its ownK093339 Eli PC ElectrocardiographMortara Instrument, Inc. · 2010 · Recalled
- Descendant · cites it directly · 5 of its ownK013354 GlobalcardioCardiocomm Solutions, Inc. · 2002
- Descendant · 2 generations on · 4 of its ownK033037 Modification to GlobalcardioCardiocomm Solutions, Inc. · 2003
- Descendant · 2 generations on · 3 of its ownK111320 GlobalcardioCardiocomm Solutions, Inc. · 2011
- Descendant · cites it directly · 3 of its ownK103640 Midmark IqecgBrentwood Medical Technology Corp. · 2011 · Recalled
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K093339Eli PC ElectrocardiographMortara Instrument, Inc. · 2010 · cites it directly6descendants
- K013354GlobalcardioCardiocomm Solutions, Inc. · 2002 · cites it directly5descendants
- K033037Modification to GlobalcardioCardiocomm Solutions, Inc. · 2003 · 2 generations on4descendants
- K111320GlobalcardioCardiocomm Solutions, Inc. · 2011 · 2 generations on3descendants
- K103640Midmark IqecgBrentwood Medical Technology Corp. · 2011 · cites it directly3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K955023 | Brentwood PC-Ecg | Brentwood Medical Products, Inc. | 1997 | — |
| +1 | K093339 | Eli PC Electrocardiograph | Mortara Instrument, Inc. | 2010 | 1 |
| +1 | K013354 | Globalcardio | Cardiocomm Solutions, Inc. | 2002 | — |
| +2 | K033037 | Modification to Globalcardio | Cardiocomm Solutions, Inc. | 2003 | — |
| +2 | K111320 | Globalcardio | Cardiocomm Solutions, Inc. | 2011 | — |
| +1 | K103640 | Midmark Iqecg | Brentwood Medical Technology Corp. | 2011 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 4 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2026 | 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (19)
See all 194 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 18, 2010 | Not classified | Z-2725-2011 | Software design | The recall was initiated because when a user of the IQmanager, IQdevices SDK, and IQiC (Centricity) software versions listed above accesses the QT dialogue box to either accept or edit the QT value, the QTc value is recalculated using a… |
| May 18, 2010 | Not classified | Z-2726-2011 | Software design | The recall was initiated because when a user of the IQmanager, IQdevices SDK, and IQiC (Centricity) software versions listed above accesses the QT dialogue box to either accept or edit the QT value, the QTc value is recalculated using a… |
| May 18, 2010 | Not classified | Z-2724-2011 | Software design | The recall was initiated because when a user of the IQmanager, IQdevices SDK, and IQiC (Centricity) software versions listed above accesses the QT dialogue box to either accept or edit the QT value, the QTc value is recalculated using a… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K093339 (Mortara Instrument, Inc., 2010) has gone furthest, with 6 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/K955023 · printed Nov 5, 2026
Cite this page
510(k) Report. “K955023: Brentwood PC-Ecg.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K955023
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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