510(k) · Cleared
ClearedNICO BrainPath & Accessories, NICO BrainPath, NICO Shepherd's Hook
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nico Corporation · GZT Retractor, Self-Retaining, For Neurosurgery
Cleared on Jun 12, 2015 as substantially equivalent to K120691 (Nico Corporation, 2012) after a 119-day review. Its family tree reaches back 4 generations to 2000. 1 of the 11 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it.
- Decided
- Jun 12, 2015
- Review
- 119 days
- Class
- Class II
- Product code
- GZT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K002931 (2000). 8 ancestors in all, the oldest K830332 (1983). 2 later devices descend from it, 1 citing it directly. 1 of the 11 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK002931 Metrx SystemMedtronic Sofamor Danek, Inc. · 2000
- 3 generations backK043602 Quadrant Retractor SystemMedtronic Sofamor Danek · 2005
- 2 generations backK060973 Vycor Surgical Access SystemsVycor Medical, LLC · 2006 · Recalled (Class I)
- 1 generation backK120691 Brain PortNico Corporation · 2012 · Recalled
- This deviceK150378 NICO BrainPath & Accessories, NICO BrainPath, NICO Shepherd's HookNico Corporation · 2015
- Descendant · cites it directly · 1 of its ownK172433 NICO BrainPathNico Corporation · 2017
- Descendant · 2 generations on · 0 of its ownK202072 MindsEye Expandable PortMinnetronix Neuro, Inc. · 2020
Class I recalls in this family
- K060973 Vycor Surgical Access Systems2 generations back · 2006
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K002931 | Metrx System | Medtronic Sofamor Danek, Inc. | 2000 | — |
| −3 | K043602 | Quadrant Retractor System | Medtronic Sofamor Danek | 2005 | — |
| −2 | K060973 | Vycor Surgical Access Systems | Vycor Medical, LLC | 2006 | Class I |
| −1 | K120691 | Brain Port | Nico Corporation | 2012 | 2 |
| 0 (this device) | K150378 | NICO BrainPath & Accessories, NICO BrainPath, NICO Shepherd's Hook | Nico Corporation | 2015 | — |
| +1 | K172433 | NICO BrainPath | Nico Corporation | 2017 | — |
| +2 | K202072 | MindsEye Expandable Port | Minnetronix Neuro, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1989 | 2 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2020 | 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.
1 device in this family has a Class I recall. 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 GZT device
- #1 K252995 Durashield Device Kitscore 12.6 · 3 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 |
|---|---|---|---|
| * | K120691 | Brain PortSummary page 4…: Self-retaining retractor for neurosurgery Classification: 21 CFR §882.4800 Product Codes: GZT Predicate Device: K120691, NICO Brain Port (previous name) Device Description The NICO BrainPath and Accessories are designed to provide minimally invasiv… | 2012 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K172433 | NICO BrainPath | 2017 | 1 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K060973Vycor Surgical Access SystemsVycor Medical, LLC · 2006 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 15 years and passes through 4 companies; a new generation was cleared every 4.2 years on median.
- 3 of the 8 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K172433 (Nico Corporation, 2017) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K120691.
How does its category compare?
All GZT devicesGZT Retractor, Self-Retaining, For Neurosurgery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · GZT
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · GZT
280in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GZT
1in 2012
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GZT
1in 2025
MAUDE reports naming product code GZT, 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 | — | 1 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 1 |
| 2010 | 1 | — | 0 | 4 |
| 2011 | 1 | — | 0 | 4 |
| 2012 | 2 | — | 1 (1) | 6 |
| 2013 | 0 | — | 0 | 12 |
| 2014 | 0 | — | 0 | 16 |
| 2015 | 1 | — | 0 | 4 |
| 2016 | 1 | — | 0 | 5 |
| 2017 | 3 | 280 | 0 | 9 |
| 2018 | 1 | — | 0 | 3 |
| 2019 | 0 | — | 0 | 5 |
| 2020 | 1 | — | 0 | 3 |
| 2021 | 1 | — | 0 | 2 |
| 2022 | 1 | — | 0 | 4 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 8 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
To provide for access and allow for visualization of the surgical field during brain and spinal surgery. Indications may include subcortical access to diseases such as the following:
- Primary/Secondary Brain Tumors
- Vascular Abnormalities/Malformations
- Intraventricular Tumors/Cysts
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150378 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150378: NICO BrainPath & Accessories, NICO BrainPath, NICO Shepherd's Hook.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150378
Report an extraction error
Are you the manufacturer?
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