510(k) · Cleared
ClearedVycor Medical Viewsite Brain Access System (“VBAS”) and VBAS with Alignment Clip (“VBAS AC”) (together the “VBAS Family”)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vycor Medical, Inc. · GZT Retractor, Self-Retaining, For Neurosurgery
Cleared on Jan 14, 2021 as substantially equivalent to K060973 (Vycor Medical, LLC, 2006) after a 120-day review. Its family tree reaches back 3 generations to 2000. 1 of the 8 devices in its family, counting itself, has a Class I recall.
- Decided
- Jan 14, 2021
- Review
- 120 days
- Class
- Class II
- Product code
- GZT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K002931 (2000). 7 ancestors in all, the oldest K830332 (1983). No later device cites it as a predicate yet. 1 of the 8 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 deviceK202694 Vycor Medical Viewsite Brain Access System (“VBAS”) and VBAS with…Vycor Medical, Inc. · 2021
Class I recalls in this family
- K060973 Vycor Surgical Access Systemsdirect predicate · 2006
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) | K202694 | Vycor Medical Viewsite Brain Access System (“VBAS”) and VBAS with Alignment… | Vycor Medical, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1989 | 2 | 0 |
| 2004 | 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
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 4…Class II Product Code: GZT Panel: Neurology 3. Predicate Device Information: Vycor ViewSite Surgical Access System (VBAS) K060973 4. Device Description: The Vycor Medical Surgical Access System (VBAS) includes a family of retractor devices of… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
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 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 21 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.
- 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. 2021, 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?
The Vycor Viewsite Brain Access System (VBAS) is intended to provide for access and allow for visualization of the surgical field during brain and spine surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K202694 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202694: Vycor Medical Viewsite Brain Access System (“VBAS”) and VBAS with Alignment Clip (“VBAS AC”) (together the “VBAS Family”).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202694
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