510(k) · Cleared
ClearedGore-Tex Regenerative Material
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
W. L. Gore & Associates, Inc. · NPK Barrier, Synthetic, Intraoral
Cleared on Jun 10, 1994 after a 737-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 12 later devices descend from it.
- Decided
- Jun 10, 1994
- Review
- 737 days
- Class
- Class II
- Product code
- NPK
- Recalls
- None
- Predicates
- 0
12 later devices descend from it, 2 citing it directly.
- This deviceK922627 Gore-Tex Regenerative MaterialW. L. Gore & Associates, Inc. · 1994
- Descendant · cites it directly · 11 of its ownK964342 Cytoplast GBROsteogenics Co. · 1997
- Descendant · 2 generations on · 7 of its ownK972278 Cytoplast Regentex Titanium 250Osteogenics Co. · 1997 · Recalled
- Descendant · 3 generations on · 2 of its ownK143327 Neoss Ti Reinforced MembraneNeoss, Ltd. · 2015
- Descendant · cites it directly · 2 of its ownK012144 CytoflexUnicare Biomedical, Inc. · 2001
- Descendant · 3 generations on · 1 of its ownK201187 Cytoplast Titanium-Reinforced PTFE MembranesOsteogenics Biomedical, Inc. · 2021
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K964342Cytoplast GBROsteogenics Co. · 1997 · cites it directly11descendants
- K972278Cytoplast Regentex Titanium 250Osteogenics Co. · 1997 · 2 generations on7descendants
- K143327Neoss Ti Reinforced MembraneNeoss, Ltd. · 2015 · 3 generations on2descendants
- K012144CytoflexUnicare Biomedical, Inc. · 2001 · cites it directly2descendants
- K201187Cytoplast Titanium-Reinforced PTFE MembranesOsteogenics Biomedical, Inc. · 2021 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K922627 | Gore-Tex Regenerative Material | W. L. Gore & Associates, Inc. | 1994 | — |
| +1 | K964342 | Cytoplast GBR | Osteogenics Co. | 1997 | — |
| +2 | K972278 | Cytoplast Regentex Titanium 250 | Osteogenics Co. | 1997 | 1 |
| +3 | K143327 | Neoss Ti Reinforced Membrane | Neoss, Ltd. | 2015 | — |
| +1 | K012144 | Cytoflex | Unicare Biomedical, Inc. | 2001 | — |
| +3 | K201187 | Cytoplast Titanium-Reinforced PTFE Membranes | Osteogenics Biomedical, Inc. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 0 |
| 2001 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NPK? 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 NPK device
- #1 K221851 Lumina-PTFE Titaniumscore 7.4 · 4 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’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (12)
See all 122 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, K964342 (Osteogenics Co., 1997) has gone furthest, with 11 descendants of its own.
How does its category compare?
All NPK devicesNPK Barrier, Synthetic, Intraoral: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NPK
3in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · NPK
529in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NPK
No recall names NPK since 2007.
Adverse event reports per year · NPK
3in 2022
MAUDE reports naming product code NPK, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 1 | — | 0 | 2 |
| 2010 | 2 | — | 0 | 13 |
| 2011 | 1 | — | 0 | 35 |
| 2012 | 0 | — | 0 | 17 |
| 2013 | 1 | — | 0 | 6 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 1 | — | 0 | 2 |
| 2022 | 1 | — | 0 | 3 |
| 2023 | 3 | 529 | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K922627 · printed Nov 6, 2026
Cite this page
510(k) Report. “K922627: Gore-Tex Regenerative Material.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K922627
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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