510(k) · Cleared
Recalled · Class II · 2012Brain Port
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 5, 2012 as substantially equivalent to K060973 (Vycor Medical, LLC, 2006) after a 90-day review. Its family tree reaches back 3 generations to 2000. 1 of the 16 devices in its family, counting itself, has a Class I recall. 8 later devices descend from it. It has been recalled 2 times.
- Decided
- Jun 5, 2012
- Review
- 90 days
- Class
- Class II
- Product code
- GZT
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 3 generations to K002931 (2000). 7 ancestors in all, the oldest K830332 (1983). 8 later devices descend from it, 2 citing it directly. 1 of the 16 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK002931 Metrx SystemMedtronic Sofamor Danek, Inc. · 2000
- 2 generations backK043602 Quadrant Retractor SystemMedtronic Sofamor Danek · 2005
- 1 generation backK060973 Vycor Surgical Access SystemsVycor Medical, LLC · 2006 · Recalled (Class I)
- This deviceK120691 Brain PortNico Corporation · 2012
- Descendant · cites it directly · 4 of its ownK182211 Aurora Surgiscope SystemRebound Therapeutics Corporation · 2019
- Descendant · 2 generations on · 3 of its ownK191861 Aurora Surgiscope SystemRebound Therapeutics · 2019
- Descendant · 3 generations on · 2 of its ownK201840 Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System…Rebound Therapeutics · 2020 · Recalled
- Descendant · cites it directly · 2 of its ownK150378 NICO BrainPath & Accessories, NICO BrainPath, NICO Shepherd's HookNico Corporation · 2015
- Descendant · 2 generations on · 1 of its ownK172433 NICO BrainPathNico Corporation · 2017
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K060973 Vycor Surgical Access Systemsdirect predicate · 2006
Most influential descendants
Showing 5 of 8 · See all- K182211Aurora Surgiscope SystemRebound Therapeutics Corporation · 2019 · cites it directly4descendants
- K191861Aurora Surgiscope SystemRebound Therapeutics · 2019 · 2 generations on3descendants
- K201840Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box)Rebound Therapeutics · 2020 · 3 generations on2descendants
- K150378NICO BrainPath & Accessories, NICO BrainPath, NICO Shepherd's HookNico Corporation · 2015 · cites it directly2descendants
- K172433NICO BrainPathNico Corporation · 2017 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K002931 | Metrx System | Medtronic Sofamor Danek, Inc. | 2000 | — |
| −2 | K043602 | Quadrant Retractor System | Medtronic Sofamor Danek | 2005 | — |
| −1 | K060973 | Vycor Surgical Access Systems | Vycor Medical, LLC | 2006 | Class I |
| 0 (this device) | K120691 | Brain Port | Nico Corporation | 2012 | — |
| +1 | K182211 | Aurora Surgiscope System | Rebound Therapeutics Corporation | 2019 | — |
| +2 | K191861 | Aurora Surgiscope System | Rebound Therapeutics | 2019 | — |
| +3 | K201840 | Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control… | Rebound Therapeutics | 2020 | 1 |
| +1 | K150378 | NICO BrainPath & Accessories, NICO BrainPath, NICO Shepherd's Hook | Nico Corporation | 2015 | — |
| +2 | K172433 | NICO BrainPath | Nico Corporation | 2017 | — |
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 |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K060973 | Vycor Surgical Access SystemsSummary page 2…eath) o Manipulator: 316 Stainless Steel o Reusable Tray: 304 Stainless Steel, Silicone Predicate Device Vycor ViewSiteWm Access System by Vycor Medical, LLC. (K060973) Summary of Technical Characteristics The Brain Port Device was compared to the predicate device in areas of components, packa… | 2006 |
What descends from it? (8)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 17, 2012 | Class II | Z-2200-2012 | Labeling mix-ups | BrainPath sheaths were mislabeled. Sheaths which measure 50mm were labeled as 60mm. The length callout on the label does not match the actual length of the sheath within the packaging resulting in an improper fit as further explained… |
| Jul 17, 2012 | Class II | Z-2201-2012 | Labeling mix-ups | BrainPath sheaths were mislabeled. Sheaths which measure 50mm were labeled as 60mm. The length callout on the label does not match the actual length of the sheath within the packaging resulting in an improper fit as further explained… |
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 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 12 years and passes through 4 companies; a new generation was cleared every 4.2 years on median.
- 2 of the 7 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K182211 (Rebound Therapeutics Corporation, 2019) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K060973.
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. 2012, 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 for use as stated in the FDA summary.
https://510kreport.com/device/K120691 · printed Nov 4, 2026
Cite this page
510(k) Report. “K120691: Brain Port.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120691
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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