510(k) · Cleared
ClearedAxonpen, Axonmonitor, Axonbox, Tablet
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Clearmind Biomedical · GWG Endoscope, Neurological
Cleared on Nov 27, 2020 as substantially equivalent to K171332 (Penumbra, Inc., 2017) and 1 other predicate after a 196-day review. Its family tree reaches back 4 generations to 1985. 1 later device descends from it.
- Decided
- Nov 27, 2020
- Review
- 196 days
- Class
- Class II
- Product code
- GWG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K853143 (1985). 15 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK853143 Cooper Laser Sonics Cusa Model 200Cooper Lasersonics, Inc. · 1985
- 3 generations backK990572 SonotomeSonokinetics, Inc. · 1999
- 2 generations backK152699 Apollo SystemPenumbra, Inc. · 2016
- 1 generation backK171332 Artemis Neuro Evacuation DevicePenumbra, Inc. · 2017
- This deviceK201308 Axonpen, Axonmonitor, Axonbox, TabletClearmind Biomedical · 2020
- Descendant · cites it directly · 0 of its ownK230125 Neuroblade SystemClearmind Biomedical · 2023
Most influential descendants
Showing 1 of 1 · See all- K230125Neuroblade SystemClearmind Biomedical · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K853143 | Cooper Laser Sonics Cusa Model 200 | Cooper Lasersonics, Inc. | 1985 | — |
| −3 | K990572 | Sonotome | Sonokinetics, Inc. | 1999 | — |
| −2 | K152699 | Apollo System | Penumbra, Inc. | 2016 | — |
| −1 | K171332 | Artemis Neuro Evacuation Device | Penumbra, Inc. | 2017 | — |
| 0 (this device) | K201308 | Axonpen, Axonmonitor, Axonbox, Tablet | Clearmind Biomedical | 2020 | — |
| +1 | K230125 | Neuroblade System | Clearmind Biomedical | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2019 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 GWG? 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 GWG device
- #1 K211202 1688 4K Camera System, L11 LED Light Source…score 22.5 · 20 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 |
|---|---|---|---|
| * | K171332 | Artemis Neuro Evacuation DeviceSummary page 4…Artemis™ Neuro Evacuation Device Predicate Device Manufacturer: Penumbra Inc. Predicate Device Premarket Notification # K171332 Predicate Device Common Name: Endoscope, neurological Predicate Device Classification & Name: 21 CFR 88… | 2017 |
| * | K190719 | Artemis Eye SystemSummary page 4…te Device: Artemis™ Eye System Predicate Device Manufacturer: Penumbra Inc. Predicate Device Premarket Notification # K190719 Predicate Device Common Name: Endoscope, neurological Predicate Device Classification & Name: 21 CFR 88… | 2019 |
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 |
|---|---|---|---|
| K230125 | Neuroblade System | 2023 | 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 35 years and passes through 4 companies; a new generation was cleared every 13.6 years on median.
- 1 of the 15 ancestors has a recall of any class.
- Of its descendants, K230125 (Clearmind Biomedical, 2023) has gone furthest, with 0 descendants of its own.
How does its category compare?
All GWG devicesGWG Endoscope, Neurological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · GWG
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GWG
269in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GWG
2in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GWG
33in 2025
MAUDE reports naming product code GWG, 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 | 3 |
| 2008 | 2 | — | 0 | 5 |
| 2009 | 0 | — | 1 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 2 | 4 |
| 2012 | 0 | — | 0 | 7 |
| 2013 | 1 | — | 0 | 3 |
| 2014 | 2 | — | 0 | 19 |
| 2015 | 0 | — | 0 | 37 |
| 2016 | 2 | — | 0 | 25 |
| 2017 | 4 | 126 | 0 | 12 |
| 2018 | 4 | 128 | 0 | 16 |
| 2019 | 3 | 156 | 0 | 10 |
| 2020 | 2 | — | 0 | 19 |
| 2021 | 3 | 106 | 0 | 21 |
| 2022 | 0 | — | 0 | 12 |
| 2023 | 5 | 269 | 0 | 9 |
| 2024 | 1 | — | 0 | 9 |
| 2025 | 2 | — | 0 | 33 |
| 2026 | 4 | 217 | 0 | — |
What is it indicated for?
The Axonpen System is indicated for the illumination and visualization of intracranial tissue and fluids and the controlled
aspiration of tissue and/or fluid during surgery of the Ventricular System or Cerebrum.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201308 · printed Nov 3, 2026
Cite this page
510(k) Report. “K201308: Axonpen, Axonmonitor, Axonbox, Tablet.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K201308
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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