# K081861: Holter LX Analysis

- Pathway: 510(k) (Traditional)
- Applicant: North East Monitoring, Inc.
- Decided: Dec 4, 2008 after 156 days
- Product code: MNR (Ventilatory Effort Recorder)
- Device class: 2
- Regulation: 21 CFR 868.2375
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K910870 (1991). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042745: Lifescreen Apnea, Del Mar Reynolds Medical, Inc. (2005) Summary page 2.
- K004007: DR180+OXY, North East Monitoring, Inc. (2001) Summary page 2.
- K930564: Holter for Windows, North East Monitoring, Inc. (1995) Summary page 2.

## Indications for use
Intended for use on adult patients only as a screening device to determine the need for clinical diagnosis and evaluation by polysomnography based on the patient's score. The ECG recording may be obtained at any location specified by a physician including home, hospital, or clinic. Subjects screened for sleep apnea should have periods of sleep of at least 4 hours duration during which the ECG is predominantly sinus rhythm in nature.

Source page: https://510kreport.com/device/K081861
Methodology: https://510kreport.com/methodology