510(k) · Cleared
ClearedTutoplast Dura
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pfrimmer-Viggo GmbH & Co. · LEM Human Lyophilized Dura Mater
Cleared on Apr 20, 1992 after a 438-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 31 later devices descend from it.
- Decided
- Apr 20, 1992
- Review
- 438 days
- Class
- Class II
- Product code
- LEM
- Recalls
- None
- Predicates
- 0
31 later devices descend from it, 2 citing it directly.
- This deviceK910555 Tutoplast DuraPfrimmer-Viggo GmbH & Co. · 1992
- Descendant · cites it directly · 30 of its ownK982180 Duragen Dural Graft MatrixIntegra Lifesciences Corp. · 1999 · Recalled
- Descendant · 2 generations on · 9 of its ownK032693 Duragen Plus Dural Graft MatrixIntegra Lifesciences Corp. · 2003 · Recalled
- Descendant · 2 generations on · 7 of its ownK041000 Durepair Dura Regeneration MatrixMedtronic Neurosurgery · 2004
- Descendant · 3 generations on · 5 of its ownK052211 Durepair Dura Regeneration MatrixMedtronic Neurosurgery · 2005
- Descendant · 3 generations on · 3 of its ownK063117 Modification to Durepair Dura Regeneration MatrixMedtronic Neurosurgery · 2006
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 31 · See all- K982180Duragen Dural Graft MatrixIntegra Lifesciences Corp. · 1999 · cites it directly30descendants
- K032693Duragen Plus Dural Graft MatrixIntegra Lifesciences Corp. · 2003 · 2 generations on9descendants
- K041000Durepair Dura Regeneration MatrixMedtronic Neurosurgery · 2004 · 2 generations on7descendants
- K052211Durepair Dura Regeneration MatrixMedtronic Neurosurgery · 2005 · 3 generations on5descendants
- K063117Modification to Durepair Dura Regeneration MatrixMedtronic Neurosurgery · 2006 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K910555 | Tutoplast Dura | Pfrimmer-Viggo GmbH & Co. | 1992 | — |
| +1 | K982180 | Duragen Dural Graft Matrix | Integra Lifesciences Corp. | 1999 | 1 |
| +2 | K032693 | Duragen Plus Dural Graft Matrix | Integra Lifesciences Corp. | 2003 | 1 |
| +2 | K041000 | Durepair Dura Regeneration Matrix | Medtronic Neurosurgery | 2004 | — |
| +3 | K052211 | Durepair Dura Regeneration Matrix | Medtronic Neurosurgery | 2005 | — |
| +3 | K063117 | Modification to Durepair Dura Regeneration Matrix | Medtronic Neurosurgery | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 4 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2010 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2022 | 1 | 0 |
| 2025 | 2 | 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.
Planning a device in LEM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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? (31)
See all 312 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?
- Of its descendants, K982180 (Integra Lifesciences Corp., 1999) has gone furthest, with 30 descendants of its own.
How does its category compare?
All LEM devicesLEM Human Lyophilized Dura Mater: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LEM
FDA has decided no LEM device since 2007.
Median 510(k) review, days · LEM
Too few LEM 510(k)s in any year since 2007 to give a median.
Recalls per year · LEM
No recall names LEM since 2007.
Adverse event reports per year · LEM
No MAUDE report names LEM since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K910555 · printed Nov 6, 2026
Cite this page
510(k) Report. “K910555: Tutoplast Dura.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K910555
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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