510(k) · Cleared
ClearedDurashield Device Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
SurGenTec, LLC · GZT Retractor, Self-Retaining, For Neurosurgery
Cleared on Sep 17, 2026 as substantially equivalent to K180610 (Geister Medizin Technik GmbH, 2018) after a 364-day review. Its family tree reaches back 3 generations to 1978.
- Decided
- Sep 17, 2026
- Review
- 364 days
- Class
- Class II
- Product code
- GZT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K780706 (1978). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK780706 Lumbar Nerve Root ShieldHeyer Schulte Corp. · 1978
- 2 generations backK003740 Miaspas Minitta Anterior Micro Surgical Transthoracic Approach…Aesculap, Inc. · 2001
- 1 generation backK180610 Geister retractor for neuro - and spine surgeryGeister Medizin Technik GmbH · 2018
- This deviceK252995 Durashield Device KitSurGenTec, LLC · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K780706 | Lumbar Nerve Root Shield | Heyer Schulte Corp. | 1978 | — |
| −2 | K003740 | Miaspas Minitta Anterior Micro Surgical Transthoracic Approach Instrumentation | Aesculap, Inc. | 2001 | — |
| −1 | K180610 | Geister retractor for neuro - and spine surgery | Geister Medizin Technik GmbH | 2018 | — |
| 0 (this device) | K252995 | Durashield Device Kit | SurGenTec, LLC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1991 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2006 | 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 K202072 MindsEye Expandable Portscore 1.4 · 6 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 |
|---|---|---|---|
| * | K180610 | Geister retractor for neuro - and spine surgerySummary page 4…& Plastic Surgery Class: II Product Codes: GZT Primary Predicate: Geister retractor for neuro – and spine surgery (K180610) Indications For Use: The DuraShield™ Device Kit is indicated for use as a nerve and soft tissue protector during spinal surgery… | 2018 |
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 48 years and passes through 4 companies; a new generation was cleared every 17.3 years on median.
- 1 of the 10 ancestors has a recall of any class.
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. 2026, 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 DuraShield™ Device Kit is indicated for use as a nerve and soft tissue protector during spinal surgery in the lumbar spine. Durashield is intended to provide shielding, guarding, and retraction of the dura, nerve roots, blood vessels, and other sensitive soft tissue structures to maintain a clear surgical field during open and minimally invasive spinal procedures.
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/K252995 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252995: Durashield Device Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252995
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026