510(k) · Cleared
ClearedBrackmann Emg Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wr Medical Electronics Co. · ETN Stimulator, Nerve
Cleared on Mar 27, 1990 after a 176-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- Mar 27, 1990
- Review
- 176 days
- Class
- Class II
- Product code
- ETN
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK895838 Brackmann Emg Monitoring SystemWr Medical Electronics Co. · 1990
- Descendant · cites it directly · 3 of its ownK063560 Hilger Dual-Stim Nerve StimulatorWr Medical Electronics Co. · 2007
- Descendant · 2 generations on · 2 of its ownK081742 Baxano Neural Localization Probe 1.75 and 1.25Baxano, Inc. · 2008
- Descendant · 3 generations on · 1 of its ownK092729 Baxano Neuro Check DeviceBaxano, Inc. · 2009
- Descendant · 4 generations on · 0 of its ownK110696 Neuro Check Device with IO-Flex WireBaxano, Inc. · 2011
Most influential descendants
Showing 4 of 4 · See all- K063560Hilger Dual-Stim Nerve StimulatorWr Medical Electronics Co. · 2007 · cites it directly3descendants
- K081742Baxano Neural Localization Probe 1.75 and 1.25Baxano, Inc. · 2008 · 2 generations on2descendants
- K092729Baxano Neuro Check DeviceBaxano, Inc. · 2009 · 3 generations on1descendant
- K110696Neuro Check Device with IO-Flex WireBaxano, Inc. · 2011 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K895838 | Brackmann Emg Monitoring System | Wr Medical Electronics Co. | 1990 | — |
| +1 | K063560 | Hilger Dual-Stim Nerve Stimulator | Wr Medical Electronics Co. | 2007 | — |
| +2 | K081742 | Baxano Neural Localization Probe 1.75 and 1.25 | Baxano, Inc. | 2008 | — |
| +3 | K092729 | Baxano Neuro Check Device | Baxano, Inc. | 2009 | — |
| +4 | K110696 | Neuro Check Device with IO-Flex Wire | Baxano, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in ETN? 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 ETN device
- #1 K251672 NIM Essence™ EMG Endotracheal Tube…score 12.3 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063560 | Hilger Dual-Stim Nerve Stimulator | 2007 | 3 |
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?
- Of its descendants, K063560 (Wr Medical Electronics Co., 2007) has gone furthest, with 3 descendants of its own.
How does its category compare?
All ETN devicesETN Stimulator, Nerve: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · ETN
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ETN
98in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ETN
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ETN
1,145in 2025
MAUDE reports naming product code ETN, 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 | 2 | — | 0 | 5 |
| 2008 | 2 | — | 1 | 5 |
| 2009 | 5 | 115 | 0 | 22 |
| 2010 | 3 | 168 | 1 | 26 |
| 2011 | 9 | 115 | 0 | 55 |
| 2012 | 7 | 179 | 0 | 187 |
| 2013 | 1 | — | 0 | 270 |
| 2014 | 2 | — | 0 | 137 |
| 2015 | 1 | — | 0 | 202 |
| 2016 | 2 | — | 1 | 145 |
| 2017 | 0 | — | 0 | 117 |
| 2018 | 0 | — | 0 | 250 |
| 2019 | 0 | — | 2 | 314 |
| 2020 | 1 | — | 1 | 238 |
| 2021 | 1 | — | 1 | 197 |
| 2022 | 2 | — | 0 | 247 |
| 2023 | 5 | 98 | 1 | 390 |
| 2024 | 2 | — | 0 | 748 |
| 2025 | 1 | — | 0 | 1,145 |
| 2026 | 2 | — | 0 | — |
https://510kreport.com/device/K895838 · printed Nov 5, 2026
Cite this page
510(k) Report. “K895838: Brackmann Emg Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K895838
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026