# K955023: Brentwood PC-Ecg

- Pathway: 510(k) (Traditional)
- Applicant: Brentwood Medical Products, Inc.
- Decided: Jan 22, 1997 after 447 days
- Product code: DSI (Detector And Alarm, Arrhythmia)
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
19 later devices descend from it; 4 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K093339: Eli PC Electrocardiograph (2010), 6 descendants of its own
- K013354: Globalcardio (2002), 5 descendants of its own
- K033037: Modification to Globalcardio (2003), 4 descendants of its own
- K111320: Globalcardio (2011), 3 descendants of its own
- K103640: Midmark Iqecg (2011), 3 descendants of its own

## Recalls of this device
- May 18, 2010 · Not classified · Z-2725-2011: 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, t
- May 18, 2010 · Not classified · Z-2726-2011: 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, t
- May 18, 2010 · Not classified · Z-2724-2011: 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, t

Source page: https://510kreport.com/device/K955023
Methodology: https://510kreport.com/methodology