510(k) · Cleared
ClearedScalp Dura Retractor, Model KS00474
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
KARL STORZ Endoscopy-America, Inc. · GZT Retractor, Self-Retaining, For Neurosurgery
Cleared on Nov 15, 2010 as substantially equivalent to K060097 (KLS-Martin L.P., 2006) and 2 other predicates after a 411-day review. Its family tree reaches back 2 generations to 1983.
- Decided
- Nov 15, 2010
- Review
- 411 days
- Class
- Class II
- Product code
- GZT
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K830332 (1983). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK830332 Budde-Halo RetractorOhio Medical Instrument Co., Inc. · 1983 · Recalled
- 1 generation backK060097 Grossman Self-Retaining Low Profile Brain Retractor, Model 04-001-00KLS-Martin L.P. · 2006
- This deviceK093054 Scalp Dura Retractor, Model KS00474KARL STORZ Endoscopy-America, Inc. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K830332 | Budde-Halo Retractor | Ohio Medical Instrument Co., Inc. | 1983 | 1 |
| −1 | K060097 | Grossman Self-Retaining Low Profile Brain Retractor, Model 04-001-00 | KLS-Martin L.P. | 2006 | — |
| 0 (this device) | 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 |
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? (3)
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 |
|---|---|---|---|
| * | K060097 | Grossman Self-Retaining Low Profile Brain Retractor, Model 04-001-00 | 2006 |
| * | K960807 | Tew Cranial/Spinal Retractor Model A1090Summary page 1…CFR 882.4800 GZT KLS-Martin, LP: Grossman Self-retaining Low Profile Brain Retractor (K0O60097) Ohio Medical Instrument Co.: TEW Cranial/Spinal Retractor Model A 1090 (K960807) Ohio Medical Instrument Co.: BUDDE Halc Retractor (K830332) Device Description: The Karl Storz Scalp Dura Retractor is a non-po… | 1996 |
| * | K830332 | Budde-Halo RetractorSummary page 1…ow Profile Brain Retractor (K0O60097) Ohio Medical Instrument Co.: TEW Cranial/Spinal Retractor Model A 1090 (K960807) Ohio Medical Instrument Co.: BUDDE Halc Retractor (K830332) Device Description: The Karl Storz Scalp Dura Retractor is a non-powered, manual, adjustable, self-retaining retractor for neu… | 1983 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 27 years and passes through 3 companies; a new generation was cleared every 23.0 years on median.
- 1 of the 3 ancestors has a recall of any class.
- 1 other device also cites its predicate K060097.
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. 2010, 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 Karl Storz Scalp Dura Retractor is intended for use to
elevate dura and scalp layers away from cranial bone
during endoscopic-assisted strip craniectomies.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K093054 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093054: Scalp Dura Retractor, Model KS00474.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093054
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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