510(k) · Cleared
ClearedGrossman Self-Retaining Low Profile Brain Retractor, Model 04-001-00
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
KLS-Martin L.P. · GZT Retractor, Self-Retaining, For Neurosurgery
Cleared on Feb 27, 2006 as substantially equivalent to K830332 (Ohio Medical Instrument Co., Inc., 1983) and 1 other predicate after a 45-day review. Its family tree reaches back 1 generation to 1983. 3 later devices descend from it.
- Decided
- Feb 27, 2006
- Review
- 45 days
- Class
- Class II
- Product code
- GZT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K830332 (1983). 2 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK830332 Budde-Halo RetractorOhio Medical Instrument Co., Inc. · 1983 · Recalled
- This deviceK060097 Grossman Self-Retaining Low Profile Brain Retractor, Model 04-001-00KLS-Martin L.P. · 2006
- Descendant · cites it directly · 1 of its ownK180610 Geister retractor for neuro - and spine surgeryGeister Medizin Technik GmbH · 2018
- Descendant · 2 generations on · 0 of its ownK252995 Durashield Device KitSurGenTec, LLC · 2026
- Descendant · cites it directly · 0 of its ownK093054 Scalp Dura Retractor, Model KS00474KARL STORZ Endoscopy-America, Inc. · 2010
Most influential descendants
Showing 3 of 3 · See all- K180610Geister retractor for neuro - and spine surgeryGeister Medizin Technik GmbH · 2018 · cites it directly1descendant
- K252995Durashield Device KitSurGenTec, LLC · 2026 · 2 generations on0descendants
- K093054Scalp Dura Retractor, Model KS00474KARL STORZ Endoscopy-America, Inc. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K830332 | Budde-Halo Retractor | Ohio Medical Instrument Co., Inc. | 1983 | 1 |
| 0 (this device) | K060097 | Grossman Self-Retaining Low Profile Brain Retractor, Model 04-001-00 | KLS-Martin L.P. | 2006 | — |
| +1 | K180610 | Geister retractor for neuro - and spine surgery | Geister Medizin Technik GmbH | 2018 | — |
| +2 | K252995 | Durashield Device Kit | SurGenTec, LLC | 2026 | — |
| +1 | K093054 | Scalp Dura Retractor, Model KS00474 | KARL STORZ Endoscopy-America, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2018 | 1 | 0 |
| 2026 | 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.
Planning a device in GZT? 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? (2)
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 |
|---|---|---|---|
| * | K830332 | Budde-Halo RetractorSummary page 1…Retractor, Self-Retaining, For Neurosurgery (OFR 882.4800) Regulatory Class: II Predicate Devices: Budde®D-Halo Retractor (K830332) lew Cranial/Spinal Retractor Model A 1090 (K960807) Device D… | 1983 |
| * | K960807 | Tew Cranial/Spinal Retractor Model A1090Summary page 1…Predicate Devices: Budde®D-Halo Retractor (K830332) lew Cranial/Spinal Retractor Model A 1090 (K960807) Device Description: The Self-Retaining Low Profile Brain Grossm… | 1996 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
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 | — |
What is it indicated for?
The Grossman Self-Retaining Low Profile Brain Retractor is designed to
retract soft tissue during neurosurgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060097 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060097: Grossman Self-Retaining Low Profile Brain Retractor, Model 04-001-00.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060097
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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