510(k) · Cleared
Recalled · 2003Budde-Halo Retractor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ohio Medical Instrument Co., Inc. · GZT Retractor, Self-Retaining, For Neurosurgery
Cleared on Mar 2, 1983 after a 29-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 17 devices in its family, counting itself, has a Class I recall. 16 later devices descend from it. It has been recalled once.
- Decided
- Mar 2, 1983
- Review
- 29 days
- Class
- Class II
- Product code
- GZT
- Recalls
- 1
- Predicates
- 0
16 later devices descend from it, 4 citing it directly. 1 of the 17 devices in this family, counting this one, has a Class I recall.
- This deviceK830332 Budde-Halo RetractorOhio Medical Instrument Co., Inc. · 1983
- Descendant · cites it directly · 10 of its ownK060973 Vycor Surgical Access SystemsVycor Medical, LLC · 2006 · Recalled (Class I)
- Descendant · 2 generations on · 8 of its ownK120691 Brain PortNico Corporation · 2012 · Recalled
- Descendant · 3 generations on · 4 of its ownK182211 Aurora Surgiscope SystemRebound Therapeutics Corporation · 2019
- Descendant · 4 generations on · 3 of its ownK191861 Aurora Surgiscope SystemRebound Therapeutics · 2019
- Descendant · cites it directly · 3 of its ownK060097 Grossman Self-Retaining Low Profile Brain Retractor, Model 04-001-00KLS-Martin L.P. · 2006
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K060973 Vycor Surgical Access Systemscites it directly · 2006
Most influential descendants
Showing 5 of 16 · See all- K060973Vycor Surgical Access SystemsVycor Medical, LLC · 2006 · cites it directly10descendants
- K120691Brain PortNico Corporation · 2012 · 2 generations on8descendants
- K182211Aurora Surgiscope SystemRebound Therapeutics Corporation · 2019 · 3 generations on4descendants
- K191861Aurora Surgiscope SystemRebound Therapeutics · 2019 · 4 generations on3descendants
- K060097Grossman Self-Retaining Low Profile Brain Retractor, Model 04-001-00KLS-Martin L.P. · 2006 · cites it directly3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K830332 | Budde-Halo Retractor | Ohio Medical Instrument Co., Inc. | 1983 | — |
| +1 | K060973 | Vycor Surgical Access Systems | Vycor Medical, LLC | 2006 | Class I |
| +2 | K120691 | Brain Port | Nico Corporation | 2012 | 2 |
| +3 | K182211 | Aurora Surgiscope System | Rebound Therapeutics Corporation | 2019 | — |
| +4 | K191861 | Aurora Surgiscope System | Rebound Therapeutics | 2019 | — |
| +1 | K060097 | Grossman Self-Retaining Low Profile Brain Retractor, Model 04-001-00 | KLS-Martin L.P. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2006 | 2 | 1 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (16)
See all 164 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060973 | Vycor Surgical Access Systems Class I | 2006 | 10 |
| K060097 | Grossman Self-Retaining Low Profile Brain Retractor, Model 04-001-00 | 2006 | 3 |
| K093054 | Scalp Dura Retractor, Model KS00474 | 2010 | 0 |
| K991267 | Spine Applications for the Mayfield/Acciss Operating Arm and Optical Acciss Systems… | 1999 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 26, 2003 | Not classified | Z-0781-03 | Other | The component was manufactured with an insufficient weld that could break during use. |
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 · Cites it directly · ◆ in the 2006 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K060973 (Vycor Medical, LLC, 2006) has gone furthest, with 10 descendants of its own.
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.
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 | — |
https://510kreport.com/device/K830332 · printed Nov 3, 2026
Cite this page
510(k) Report. “K830332: Budde-Halo Retractor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K830332
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026