510(k) · Cleared
ClearedSnap II Eeg Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Everest Biomedical Instruments Co. · OLW Index-Generating Electroencephalograph Software
Cleared on Jun 15, 2006 as substantially equivalent to K020218 (Nicolet Biomedical, Inc., 2002) after a 66-day review. Its family tree reaches back 3 generations to 1988.
- Decided
- Jun 15, 2006
- Review
- 66 days
- Class
- Class II
- Product code
- OLW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K874685 (1988). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK874685 Trans-Scan 3-D Transcranial DopplerCarolina Medical Electronics · 1988
- 2 generations backK991054 Bravo Multi-Modality SystemNicolet Biomedical, Inc. · 1999 · Recalled
- 1 generation backK020218 Snap Eeg MonitorNicolet Biomedical, Inc. · 2002
- This deviceK060997 Snap II Eeg MonitorEverest Biomedical Instruments Co. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K874685 | Trans-Scan 3-D Transcranial Doppler | Carolina Medical Electronics | 1988 | — |
| −2 | K991054 | Bravo Multi-Modality System | Nicolet Biomedical, Inc. | 1999 | 4 |
| −1 | K020218 | Snap Eeg Monitor | Nicolet Biomedical, Inc. | 2002 | — |
| 0 (this device) | K060997 | Snap II Eeg Monitor | Everest Biomedical Instruments Co. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1996 | 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 OLW? 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 OLW device
- #1 K260880 SedLine Sedation Monitorscore 17.0 · 19 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K020218 | Snap Eeg MonitorSummary page 2…followed in the development of this device. Sestion-5—Page-2-of 3 Predicate Device Table Predicate Classification(s) Nicolet SNAP EEC Monitor Class 1l (K020218) 882.1400 GWQ Intended Use The SNAP II is intended to monitor the state of the brain by data acquisition of EEG signals. A deri… | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
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 18 years and passes through 3 companies; a new generation was cleared every 4.1 years on median.
- 1 of the 6 ancestors has a recall of any class.
How does its category compare?
All OLW devicesOLW Index-Generating Electroencephalograph Software: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · OLW
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · OLW
105in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OLW
No recall names OLW since 2007.
Adverse event reports per year · OLW
73in 2025
MAUDE reports naming product code OLW, 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 | 3 | 105 | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 1 | — | 0 | 3 |
| 2019 | 0 | — | 0 | 6 |
| 2020 | 0 | — | 0 | 15 |
| 2021 | 1 | — | 0 | 15 |
| 2022 | 1 | — | 0 | 27 |
| 2023 | 1 | — | 0 | 18 |
| 2024 | 1 | — | 0 | 93 |
| 2025 | 0 | — | 0 | 73 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The SNAP Il is intended to monitor the state of the brain by data acquisition of EEG signals. A derived measure provided by the SNAP I, the SNAP Index, indicates the patient’s brain activity level.
The SNAP II is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use, within a hospital or medical facility providing patient care.
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/K060997 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060997: Snap II Eeg Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060997
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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