# K984580: Biosaca System

- Pathway: 510(k) (Traditional)
- Applicant: Biosys AB (Publ)
- Decided: Mar 12, 1999 after 79 days
- Product code: OLV (Standard Polysomnograph With 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: 2 generations back to K873535 (1987). 11 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955841: Sleep System for Clinics & Research, Compumedics Ptd, Ltd. (1997) Summary page 2.
- K971813: EMBLA, Ferguson Medical (1998) Summary page 2.

## Most influential descendants
- K991446: Biosaca System, Model 800 (1999), 0 descendants of its own

## Indications for use
The BIOSACA equipment is indicated for use in the recording, displaying, monitoring, printing and storage of biological and non-biological signals for sleep disorder and epilepsy investigations as well as Electroencephalography (EEG), Electrocardiography (ECG), Electromyography (EMG), Electrooculography (EOG), Ballistocardiography, etc. BIOSACA is designed for both stationary and mobile operation and may be used in either the patient's home or the hospital. Biological signals are electrical signals which can be recorded directly from the patient. Non-biological signals are recorded using indirect methods such as recording the flow of air (breathing), blood pressure, etc. The equipment is suitable for home use as the patient needs only a minimal amount of instruction in how to use it. The system has no lights or sounds that could confuse the patient. Signals may be stored for later or may be viewed directly in real-time in the hospital, for instance. When monitoring, the operator sces the signals at the same time as they are recorded. The Biosaca unit is intended for use on an adult population and at home or in health care facilities. It is not intended for use as life support equipment such as vital signs monitoring in intensive care units.

Source page: https://510kreport.com/device/K984580
Methodology: https://510kreport.com/methodology