# K072008: Braemar ER900 Wireless Series Arrhythmia Event Recorder

- Pathway: 510(k) (Traditional)
- Applicant: Braemar, Inc.
- Decided: Oct 3, 2007 after 72 days
- Product code: DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency)
- Device class: 2
- Regulation: 21 CFR 870.2910
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K112601: Intricon Datrix Sirona Event/ Holter Recorder (2011), 0 descendants of its own

## Recalls of this device
- Feb 24, 2012 · Class II · Z-1652-2013: Braemar has recently became aware of a battery related incident that occurred with EWT battery packs that are used in a Braemer ER920W wireless event monitor and Fusion device. The event did not resul
- May 2, 2011 · Class II · Z-1645-2013: Braemar Inc., became aware of a battery related incident that occurred with an Able battery pack being used in a Braemar ER920W wireless event monitor. The event did not result in any patient related 

Source page: https://510kreport.com/device/K072008
Methodology: https://510kreport.com/methodology