# K004007: DR180+OXY

- Pathway: 510(k) (Special)
- Applicant: North East Monitoring, Inc.
- Decided: Jan 25, 2001 after 30 days
- Product code: DSH (Recorder, Magnetic Tape, Medical)
- Device class: 2
- Regulation: 21 CFR 870.2800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K081861: Holter LX Analysis (2008), 0 descendants of its own
- K051686: Cardiomem CM 3000-12 (2005), 0 descendants of its own

Source page: https://510kreport.com/device/K004007
Methodology: https://510kreport.com/methodology