510(k) · Cleared
Recalled · 2007Ceegraph/Sleepscan Netlink Traveler
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Logic Systems Corp. · OLV Standard Polysomnograph With Electroencephalograph
Cleared on Aug 26, 2005 as substantially equivalent to K002570 (Bio-Logic Systems Corp., 2000) and 3 other predicates after a 25-day review. Its family tree reaches back 2 generations to 1994. 5 later devices descend from it. It has been recalled 2 times.
- Decided
- Aug 26, 2005
- Review
- 25 days
- Class
- Class II
- Product code
- OLV
- Recalls
- 2
- Predicates
- 4
Its longest line of descent runs back 2 generations to K930790 (1994). 5 ancestors in all. 5 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK930790 Addition of Built-in Oxymeter to Sleepscan Prod.Bio-Logic Systems Corp. · 1994
- 1 generation backK962103 Bio-Logic Sleepscan Product with Built-in OximeterBio-Logic Systems Corp. · 1996
- This deviceK052066 Ceegraph/Sleepscan Netlink TravelerBio-Logic Systems Corp. · 2005
- Descendant · cites it directly · 4 of its ownK093728 BE Micro, TreaEb Neuro S.P.A. · 2010
- Descendant · 2 generations on · 3 of its ownK133355 Cadwell Flex Eeg/PSGCadwell Industries, Inc. · 2014
- Descendant · 3 generations on · 2 of its ownK180269 Cadwell Apollo SystemCadwell Industries, Inc. · 2018
- Descendant · 4 generations on · 1 of its ownK201819 Cadwell Apollo SystemCadwell Industries, Inc. · 2020
- Descendant · 5 generations on · 0 of its ownK221959 Q21Neurofield, Inc. · 2023
Most influential descendants
Showing 5 of 5 · See all- K093728BE Micro, TreaEb Neuro S.P.A. · 2010 · cites it directly4descendants
- K133355Cadwell Flex Eeg/PSGCadwell Industries, Inc. · 2014 · 2 generations on3descendants
- K180269Cadwell Apollo SystemCadwell Industries, Inc. · 2018 · 3 generations on2descendants
- K201819Cadwell Apollo SystemCadwell Industries, Inc. · 2020 · 4 generations on1descendant
- K221959Q21Neurofield, Inc. · 2023 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K930790 | Addition of Built-in Oxymeter to Sleepscan Prod. | Bio-Logic Systems Corp. | 1994 | — |
| −1 | K962103 | Bio-Logic Sleepscan Product with Built-in Oximeter | Bio-Logic Systems Corp. | 1996 | — |
| 0 (this device) | K052066 | Ceegraph/Sleepscan Netlink Traveler | Bio-Logic Systems Corp. | 2005 | — |
| +1 | K093728 | BE Micro, Trea | Eb Neuro S.P.A. | 2010 | — |
| +2 | K133355 | Cadwell Flex Eeg/PSG | Cadwell Industries, Inc. | 2014 | — |
| +3 | K180269 | Cadwell Apollo System | Cadwell Industries, Inc. | 2018 | — |
| +4 | K201819 | Cadwell Apollo System | Cadwell Industries, Inc. | 2020 | — |
| +5 | K221959 | Q21 | Neurofield, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2000 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 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? (4)
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 |
|---|---|---|---|
| * | K002570 | Bio-Logic Ceegraph NetlinkSummary page 1…Digital EEBG/Sleep Recorder. CLASSIFICATION NAME: Electroencephalograph (per CFR 882.1400). PREDICATE DEVICE: Bio-logic Ceegraph Netlink (K002570), Sleepscan Netlink (K003681I), Ceegraph Traveler (K954954) and Sleepscan Traveler (K962 103).… | 2000 |
| * | K003681 | Bio-Logic Sleepscan NetlinkSummary page 1…p Recorder. CLASSIFICATION NAME: Electroencephalograph (per CFR 882.1400). PREDICATE DEVICE: Bio-logic Ceegraph Netlink (K002570), Sleepscan Netlink (K003681I), Ceegraph Traveler (K954954) and Sleepscan Traveler (K962 103).… | 2000 |
| * | K954954 | Ceegraph Traveler Ambulatory Eeg RecorderSummary page 1…AME: Electroencephalograph (per CFR 882.1400). PREDICATE DEVICE: Bio-logic Ceegraph Netlink (K002570), Sleepscan Netlink (K003681I), Ceegraph Traveler (K954954) and Sleepscan Traveler (K962 103).… | 1996 |
| * | K962103 | Bio-Logic Sleepscan Product with Built-in OximeterSummary page 1…halograph (per CFR 882.1400). PREDICATE DEVICE: Bio-logic Ceegraph Netlink (K002570), Sleepscan Netlink (K003681I), Ceegraph Traveler (K954954) and Sleepscan Traveler (K962 103). Page 8… | 1996 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093728 | BE Micro, Trea | 2010 | 4 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 26, 2007 | Not classified | Z-0001-2008 | Device Design | Bio-logic System Corp Camera Pole may weaken and detach at the base of the telescoping camera pole during transport causing pole to break at the welded base and fall. |
| Feb 26, 2007 | Not classified | Z-0761-2007 | Other | Battery and Battery Compartment; incorrect placement in the Netlink Traveler unit which caused a short in the wiring of the battery pack and overheating. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 1 company; a new generation was cleared every 9.0 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K093728 (Eb Neuro S.P.A., 2010) has gone furthest, with 4 descendants of its own.
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 Bio-logic Ceegraph/Sleepscan Netlink Traveler is indicated for use in the recording and analysis of EEG tests. Typical routine EEG tests are 20-30 minutes in duration, but the Ceegraph/Sleepscan Netlink Traveler can also be used for longer tests, including continuous long-term EEG monitoring with patient video. Similarly, the Bio-logic Ceegraph/Sleepscan Netlink Traveler is indicated for use in the recording and analysis of human physiological data…
Read the full statement (179 words)
The Bio-logic Ceegraph/Sleepscan Netlink Traveler is indicated for use in the recording and analysis of EEG tests. Typical routine EEG tests are 20-30 minutes in duration, but the Ceegraph/Sleepscan Netlink Traveler can also be used for longer tests, including continuous long-term EEG monitoring with patient video. Similarly, the Bio-logic Ceegraph/Sleepscan Netlink Traveler is indicated for use in the recording and analysis of human physiological data necessary for the diagnosis of Sleep-related disorders. It is intended to record and present this data in a form that can improve the speed of diagnosis and assist in potential treatment decisions. In general, EEG and Sleep testing is indicated for use whenever it is necessary to measure and record a patient's electrophysiological activity, including the electrical activity of the brain, by attaching multiple electrodes at various locations on the body.
The Netlink Traveler can be used for patients of all ages, from children to adults, including geriatric patients.
The use of the Ceegraph/Sleepscan Netlink Traveler is to be performed under the prescription and supervision of a physician or other trained health care professional.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052066 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052066: Ceegraph/Sleepscan Netlink Traveler.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052066
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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