510(k) · Cleared
ClearedBiosaca System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biosys AB (Publ) · OLV Standard Polysomnograph With Electroencephalograph
Cleared on Mar 12, 1999 as substantially equivalent to K955841 (Compumedics Ptd, Ltd., 1997) and 1 other predicate after a 79-day review. Its family tree reaches back 2 generations to 1987. 1 later device descends from it.
- Decided
- Mar 12, 1999
- Review
- 79 days
- Class
- Class II
- Product code
- OLV
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K873535 (1987). 11 ancestors in all, the oldest K830295 (1983). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK873535 Nicolet Expert Sleep/Wake Analysis SystemNicolet Biomedical Instruments · 1987
- 1 generation backK955841 Sleep System for Clinics & ResearchCompumedics Ptd, Ltd. · 1997
- This deviceK984580 Biosaca SystemBiosys AB (Publ) · 1999
- Descendant · cites it directly · 0 of its ownK991446 Biosaca System, Model 800Biosys AB (Publ) · 1999
Most influential descendants
Showing 1 of 1 · See all- K991446Biosaca System, Model 800Biosys AB (Publ) · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K873535 | Nicolet Expert Sleep/Wake Analysis System | Nicolet Biomedical Instruments | 1987 | — |
| −1 | K955841 | Sleep System for Clinics & Research | Compumedics Ptd, Ltd. | 1997 | — |
| 0 (this device) | K984580 | Biosaca System | Biosys AB (Publ) | 1999 | — |
| +1 | K991446 | Biosaca System, Model 800 | Biosys AB (Publ) | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1986 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OLV? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new OLV device
- #1 K241288 Noxturnal Webscore 17.3 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K955841 | Sleep System for Clinics & ResearchSummary page 2…ester, New York 10918 Tel. 914-469-4289 Fax. 914-469-4212 e-mail: [email protected] Predicate Devices Compumedics Sleep Monitoring System, Compumedics Sleep Pty. Ltd (K955841) Embla, Flaga hf. (K971813) Device Description The BIOSACA is a multi-functional and an ambulatory ; recording device. It is a… | 1997 |
| * | K971813 | EMBLASummary page 2…914-469-4289 Fax. 914-469-4212 e-mail: [email protected] Predicate Devices Compumedics Sleep Monitoring System, Compumedics Sleep Pty. Ltd (K955841) Embla, Flaga hf. (K971813) Device Description The BIOSACA is a multi-functional and an ambulatory ; recording device. It is a portable system for the reco… | 1998 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K991446 | Biosaca System, Model 800 | 1999 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 9.4 years on median.
- 1 of the 11 ancestors has a recall of any class.
- Of its descendants, K991446 (Biosys AB (Publ), 1999) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K955841.
How does its category compare?
All OLV devicesOLV Standard Polysomnograph With Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · OLV
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OLV
141in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OLV
No recall names OLV since 2007.
Adverse event reports per year · OLV
1in 2025
MAUDE reports naming product code OLV, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 3 | 83 | 0 | 0 |
| 2018 | 3 | 141 | 0 | 3 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 1 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 2 | — | 0 | 2 |
| 2025 | 1 | — | 0 | 1 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (196 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K984580 · printed Nov 6, 2026
Cite this page
510(k) Report. “K984580: Biosaca System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K984580
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026