510(k) · Cleared
ClearedBwii Eeg Digital, Model PV 1652; Bwii PSG Digital, Model PV 1524
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neurovirtual USA, Inc. · OLT Non-Normalizing Quantitative Electroencephalograph Software
Cleared on Dec 22, 2006 as substantially equivalent to K932407 (Cadwell Laboratories, Inc., 1994) and 3 other predicates after a 115-day review. Its family tree reaches back 1 generation to 1994. 1 later device descends from it.
- Decided
- Dec 22, 2006
- Review
- 115 days
- Class
- Class II
- Product code
- OLT
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K932407 (1994). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK932407 Cadwell Easy Writer and Easy ReaderCadwell Laboratories, Inc. · 1994
- This deviceK062533 Bwii Eeg Digital, Model PV 1652; Bwii PSG Digital, Model PV 1524Neurovirtual USA, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK112107 Bwiii Eeg, Bwiii Eeg Plus, Bwiii PSG, Bwiii PSG PlusNeurovirtual USA, Inc. · 2011
Most influential descendants
Showing 1 of 1 · See all- K112107Bwiii Eeg, Bwiii Eeg Plus, Bwiii PSG, Bwiii PSG PlusNeurovirtual USA, Inc. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K932407 | Cadwell Easy Writer and Easy Reader | Cadwell Laboratories, Inc. | 1994 | — |
| 0 (this device) | K062533 | Bwii Eeg Digital, Model PV 1652; Bwii PSG Digital, Model PV 1524 | Neurovirtual USA, Inc. | 2006 | — |
| +1 | K112107 | Bwiii Eeg, Bwiii Eeg Plus, Bwiii PSG, Bwiii PSG Plus | Neurovirtual USA, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 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 OLT? 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 OLT device
- #1 K253767 UB ERP Systemscore 14.9 · 12 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 |
|---|---|---|---|
| * | K932407 | Cadwell Easy Writer and Easy ReaderSummary page 1…alence: AR OO 1. — g The BWII Digital (Amplifier and Power Module) is equivalent with the fd"&wlng = products: i 3_>_ ol 510(k) Number Model Manufacture = ™ . Cadwell - K932407 Easy Write and Easy Reader Laboratories, Inc. XLTEC PSG-40 K991900 Polysomnography Excgl Tech Ltd. G 9 (. 5) 231… | 1994 |
| * | K991900 | Xltek Polysomnography Headbox, Model # PSG-40Summary page 1…is equivalent with the fd"&wlng = products: i 3_>_ ol 510(k) Number Model Manufacture = ™ . Cadwell - K932407 Easy Write and Easy Reader Laboratories, Inc. XLTEC PSG-40 K991900 Polysomnography Excgl Tech Ltd. G 9 (. 5) 2315NW 107th Avenue - B.133 - WH. 1A16 ‘%Q é ‘56 Lf 4’ NEURGVIRTUAL… | 1999 |
| * | K980214 | Excel Neuro WorksSummary page 2…RTUAL Doral FL - USA - 33172 Phone: (786) 693-8200 - Fax (305) 393-8429 And the BWAnalysis software is equivalent with the following: 510(k) Number Model Manufacture K980214 Excel Neuro Works Excel Tech Ltd. . Cadwell K932407 Easy Write and Easy Reader Laboratories, Inc. . Persyst K974718 Persyst Prism… | 1998 |
| * | K974718 | Persyst PrismSummary page 2…with the following: 510(k) Number Model Manufacture K980214 Excel Neuro Works Excel Tech Ltd. . Cadwell K932407 Easy Write and Easy Reader Laboratories, Inc. . Persyst K974718 Persyst Prism Development Corp. F) Description: B8WII is multi-channel (up to 25 channels) system designed for electroencephalo… | 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 |
|---|---|---|---|
| K112107 | Bwiii Eeg, Bwiii Eeg Plus, Bwiii PSG, Bwiii PSG Plus | 2011 | 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?
How does its category compare?
All OLT devicesOLT Non-Normalizing Quantitative Electroencephalograph Software: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · OLT
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OLT
266in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OLT
No recall names OLT since 2007.
Adverse event reports per year · OLT
3in 2025
MAUDE reports naming product code OLT, 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 | 1 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 5 | 266 | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 7 |
| 2019 | 2 | — | 0 | 2 |
| 2020 | 1 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 6 |
| 2022 | 2 | — | 0 | 4 |
| 2023 | 0 | — | 0 | 5 |
| 2024 | 1 | — | 0 | 4 |
| 2025 | 2 | — | 0 | 3 |
| 2026 | 3 | 217 | 0 | — |
What is it indicated for?
The BWII system may be used for electroencephalography (EEG) and sleep recordings (polysomnography) in research and dinical environments. It acquires, displays, and archives EEG and PSG data for on screen review, annotation and event marking by the user. The BWII system also allows for computer-assisted, user-controlled quantitative analysis of EEG. The BWII system is not intended to replace conventional devices or methods used for EEG and PSG monitoring…
Read the full statement (142 words)
The BWII system may be used for electroencephalography (EEG) and sleep recordings (polysomnography) in research and dinical environments. It acquires, displays, and archives EEG and PSG data for on screen review, annotation and event marking by the user. The BWII system also allows for computer-assisted, user-controlled quantitative analysis of EEG.
The BWII system is not intended to replace conventional devices or methods used for EEG and PSG monitoring in critical care or intraoperative settings.
The BWII system requires competent user input, and its output must be reviewed and interpreted by a trained technicians or neurologists who will exercise professional judgment in using this information.
The BWII system does not make any judgment of normality or abnormality of the displayed signals or the results of an analysis. In no way are any of the functions represented as being in and of themselves diagnostic.
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/K062533 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062533: Bwii Eeg Digital, Model PV 1652; Bwii PSG Digital, Model PV 1524.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062533
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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