# K152301: Background Pattern Classification [BPc (TM)]

- Pathway: 510(k) (Traditional)
- Applicant: Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)
- Decided: Jun 3, 2016 after 294 days
- Product code: OMA (Amplitude-Integrated Electroencephalograph)
- Device class: 2
- Regulation: 21 CFR 882.1400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K875179 (1988). 66 ancestors in all.
No later device cites it as a predicate yet.
0 of 67 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092573: Nihon Kohden QP-160AK Eeg Trend Program, Nihon Kohden America, Inc. (2010) Summary page 4.

## Indications for use
The Background Pattern Classification algorithm is intended for: • Neonatal patients, defined as from birth to 28 days post-delivery, and corresponding to a post-conceptual age of 37 to 46 weeks, in clinical environments such as the intensive care unit, operating room, and for clinical research. • To analyze and identify background patterns in aEEG, including continuous and discontinuous activity, burst suppression, low voltage, and inactive patterns. The aEEG must be obtained from a pair of parietal electrodes located at positions corresponding with P3 and P4 of the International 10/20 System. The output of the background pattern classification algorithm must be reviewed and interpreted by qualified clinical practitioners. The device does not provide any diagnostic conclusion about the patient's condition.

Source page: https://510kreport.com/device/K152301
Methodology: https://510kreport.com/methodology