510(k) · Cleared
ClearedClearPath Disposable Introducer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Clearmind Biomedical · GWG Endoscope, Neurological
Cleared on Apr 2, 2021 as substantially equivalent to K142315 (Aesculap, Inc., 2014) after a 63-day review. Its family tree reaches back 1 generation to 2014.
- Decided
- Apr 2, 2021
- Review
- 63 days
- Class
- Class II
- Product code
- GWG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K142315 (2014). No later device cites it as a predicate yet.
- Root · 1 generation backK142315 MINOP Disposable Introducer 26FAesculap, Inc. · 2014
- This deviceK210251 ClearPath Disposable IntroducerClearmind Biomedical · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K142315 | MINOP Disposable Introducer 26F | Aesculap, Inc. | 2014 | — |
| 0 (this device) | K210251 | ClearPath Disposable Introducer | Clearmind Biomedical | 2021 | — |
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? (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 |
|---|---|---|---|
| * | K142315 | MINOP Disposable Introducer 26FSummary page 4…evice Manufacturer: Aesculap Inc. Predicate Device Common Name: Endoscope, Neurological Predicate Device Premarket Notification # K142315 Predicate Device Classification & Name 21 CFR 882.1480 Predicate Device Classification & Class II Product… | 2014 |
| † | K061135 | Minop Disposable Introducer 10F, Model ME010; 19F, Model ME019 | 2006 |
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?
- Its one ancestor has no recall.
How does its category compare?
All GWG devicesGWG Endoscope, Neurological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 ClearPath Disposable Introducer is indicated to obtain and maintain a temporary pathway into the ventricular system and cerebrum of the brain.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210251 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210251: ClearPath Disposable Introducer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210251
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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