510(k) · Cleared
ClearedFastube Nerve Regeneration Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Research Medical, Inc. · JXI Cuff, Nerve
Cleared on Jul 10, 1985 after a 134-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 38 later devices descend from it.
- Decided
- Jul 10, 1985
- Review
- 134 days
- Class
- Class II
- Product code
- JXI
- Recalls
- None
- Predicates
- 0
38 later devices descend from it, 2 citing it directly.
- This deviceK850785 Fastube Nerve Regeneration DeviceResearch Medical, Inc. · 1985
- Descendant · cites it directly · 37 of its ownK012814 Collagen Nerve CuffCollagen Matrix, Inc. · 2001
- Descendant · cites it directly · 22 of its ownK060952 Collagen Nerve WrapCollagen Matrix, Inc. · 2006
- Descendant · 2 generations on · 15 of its ownK080452 Collagen Tendon WrapCollagen Matrix, Inc. · 2008
- Descendant · 3 generations on · 14 of its ownK112423 Collagen Tendon SheetRotation Medical, Inc. · 2011
- Descendant · 2 generations on · 10 of its ownK031069 Surgisis Nerve CuffCook Biotech, Inc. · 2003
Showing 5 of 38 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 38 · See all- K012814Collagen Nerve CuffCollagen Matrix, Inc. · 2001 · cites it directly37descendants
- K060952Collagen Nerve WrapCollagen Matrix, Inc. · 2006 · cites it directly22descendants
- K080452Collagen Tendon WrapCollagen Matrix, Inc. · 2008 · 2 generations on15descendants
- K112423Collagen Tendon SheetRotation Medical, Inc. · 2011 · 3 generations on14descendants
- K031069Surgisis Nerve CuffCook Biotech, Inc. · 2003 · 2 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K850785 | Fastube Nerve Regeneration Device | Research Medical, Inc. | 1985 | — |
| +1 | K012814 | Collagen Nerve Cuff | Collagen Matrix, Inc. | 2001 | — |
| +1 | K060952 | Collagen Nerve Wrap | Collagen Matrix, Inc. | 2006 | — |
| +2 | K080452 | Collagen Tendon Wrap | Collagen Matrix, Inc. | 2008 | — |
| +3 | K112423 | Collagen Tendon Sheet | Rotation Medical, Inc. | 2011 | — |
| +2 | K031069 | Surgisis Nerve Cuff | Cook Biotech, Inc. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 4 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 5 | 0 |
| 2024 | 4 | 0 |
| 2025 | 5 | 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 JXI? 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 JXI device
- #1 K232029 VersaWrap Nerve Protectorscore 12.6 · 2 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (38)
See all 382 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, K012814 (Collagen Matrix, Inc., 2001) has gone furthest, with 37 descendants of its own.
How does its category compare?
All JXI devicesJXI Cuff, Nerve: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JXI
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JXI
99in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JXI
No recall names JXI since 2007.
Adverse event reports per year · JXI
18in 2025
MAUDE reports naming product code JXI, 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 | 7 |
| 2009 | 0 | — | 0 | 7 |
| 2010 | 1 | — | 0 | 8 |
| 2011 | 1 | — | 0 | 11 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 7 |
| 2014 | 3 | 309 | 0 | 7 |
| 2015 | 1 | — | 0 | 5 |
| 2016 | 3 | 117 | 0 | 8 |
| 2017 | 3 | 90 | 0 | 9 |
| 2018 | 1 | — | 0 | 6 |
| 2019 | 1 | — | 0 | 10 |
| 2020 | 1 | — | 0 | 5 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 2 | — | 0 | 8 |
| 2023 | 3 | 122 | 0 | 15 |
| 2024 | 3 | 266 | 0 | 18 |
| 2025 | 4 | 99 | 0 | 18 |
| 2026 | 2 | — | 0 | — |
https://510kreport.com/device/K850785 · printed Nov 6, 2026
Cite this page
510(k) Report. “K850785: Fastube Nerve Regeneration Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K850785
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026