510(k) · Cleared
ClearedSnap Eeg Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nicolet Biomedical, Inc. · OLW Index-Generating Electroencephalograph Software
Cleared on Apr 22, 2002 as substantially equivalent to K952347 (Aspect Medical Systems, Inc., 1996) and 1 other predicate after a 90-day review. Its family tree reaches back 2 generations to 1988. 1 later device descends from it.
- Decided
- Apr 22, 2002
- Review
- 90 days
- Class
- Class II
- Product code
- OLW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K874685 (1988). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK874685 Trans-Scan 3-D Transcranial DopplerCarolina Medical Electronics · 1988
- 1 generation backK991054 Bravo Multi-Modality SystemNicolet Biomedical, Inc. · 1999 · Recalled
- This deviceK020218 Snap Eeg MonitorNicolet Biomedical, Inc. · 2002
- Descendant · cites it directly · 0 of its ownK060997 Snap II Eeg MonitorEverest Biomedical Instruments Co. · 2006
Most influential descendants
Showing 1 of 1 · See all- K060997Snap II Eeg MonitorEverest Biomedical Instruments Co. · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K874685 | Trans-Scan 3-D Transcranial Doppler | Carolina Medical Electronics | 1988 | — |
| −1 | K991054 | Bravo Multi-Modality System | Nicolet Biomedical, Inc. | 1999 | 4 |
| 0 (this device) | K020218 | Snap Eeg Monitor | Nicolet Biomedical, Inc. | 2002 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 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? (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 |
|---|---|---|---|
| * | K952347 | A-1050 Eeg MonitorSummary page 1…anson, Manager of Standards and Compliance 608 441-2065 608 441-2007 January 17, 2002 SNAP EEG Monitor 21 CFR 882.1400; Product Code: (Z-W, oMc. 08T 510(k) Number: K952347 Manufacture: ASPECT Medical Inc. Trade Name: A-1050 EEG Monitor 510(k) Number: K991054 Manufacture: Nicolet Biomedical Trade Nam… | 1996 |
| * | K991054 | Bravo Multi-Modality SystemSummary page 1…SNAP EEG Monitor 21 CFR 882.1400; Product Code: (Z-W, oMc. 08T 510(k) Number: K952347 Manufacture: ASPECT Medical Inc. Trade Name: A-1050 EEG Monitor 510(k) Number: K991054 Manufacture: Nicolet Biomedical Trade Name: Bravo Endeavor Multi-Medality System 1.0 Description of Device The SNAP device reco… | 1999 |
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 |
|---|---|---|---|
| K060997 | Snap II Eeg Monitor | 2006 | 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 14 years and passes through 2 companies; a new generation was cleared every 11.5 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K060997 (Everest Biomedical Instruments Co., 2006) has gone furthest, with 0 descendants of its own.
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 device is intended to monitor a patient's EEG. A derived EEG measure, the SNAP Index, indicates the patient's brain activity level. The SNAP device is used under the guidance and interpretation of a licensed medical professional.
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/K020218 · printed Nov 5, 2026
Cite this page
510(k) Report. “K020218: Snap Eeg Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K020218
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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