510(k) · Cleared
ClearedEluPro Antibiotic-Eluting BioEnvelope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific · FTM Mesh, Surgical
Cleared on Aug 12, 2026 as substantially equivalent to K233991 (Elutia, Inc., 2024) after a 28-day review. Its family tree reaches back 12 generations to 1993.
- Decided
- Aug 12, 2026
- Review
- 28 days
- Class
- Class II
- Product code
- FTM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K931386 (1993). 23 ancestors in all, the oldest K922916 (1992). No later device cites it as a predicate yet.
- Root · 12 generations backK931386 Hemashield Microvel/Woven Double Velour FabricMeadox Medicals, Div. Boston Scientific Corp. · 1993
- 8 generations between
- 3 generations backK180030 TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable…Medtronic, Inc. · 2018
- 2 generations backK192389 TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable…Medtronic, Inc. · 2020
- 1 generation backK233991 CanGaroo RM Antibacterial EnvelopeElutia, Inc. · 2024
- This deviceK262406 EluPro Antibiotic-Eluting BioEnvelopeBoston Scientific · 2026
Show all 12 generations
- Root · 12 generations backK931386 Hemashield Microvel/Woven Double Velour FabricMeadox Medicals, Div. Boston Scientific Corp. · 1993
- 11 generations backK963611 Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek…Vascutek, Ltd. · 1996 · Recalled
- 10 generations backK972651 IN-SlingInfluence, Inc. · 1997
- 9 generations backK980482 Triangle SlingInfluence, Inc. · 1998
- 8 generations backK002721 Ams Triangle Silicone-Coated Sling and Surgical MeshAmerican Medical Systems, Inc. · 2000
- 7 generations backK042592 Intemesh Silicone-Coated Sling and Surgical Mesh with Inhibizone…American Medical Systems, Inc. · 2004
- 6 generations backK053656 Tyrx Antimicrobial MeshTyrx Pharma, Inc. · 2006
- 5 generations backK063091 Pivit CRM (Tyrx Antimicrobial Pacemaker Pouch), Model CMRM-0601Tyrx Pharma, Inc. · 2008 · Recalled
- 4 generations backK130943 Aigis RX R PM/ Aigis RX R IcdTyrx, Inc. · 2013
- 3 generations backK180030 TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable…Medtronic, Inc. · 2018
- 2 generations backK192389 TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable…Medtronic, Inc. · 2020
- 1 generation backK233991 CanGaroo RM Antibacterial EnvelopeElutia, Inc. · 2024
- This deviceK262406 EluPro Antibiotic-Eluting BioEnvelopeBoston Scientific · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K931386 | Hemashield Microvel/Woven Double Velour Fabric | Meadox Medicals, Div. Boston Scientific Corp. | 1993 | — |
| −11 | K963611 | Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek Gelsoft… | Vascutek, Ltd. | 1996 | 1 |
| −10 | K972651 | IN-Sling | Influence, Inc. | 1997 | — |
| −9 | K980482 | Triangle Sling | Influence, Inc. | 1998 | — |
| −8 | K002721 | Ams Triangle Silicone-Coated Sling and Surgical Mesh | American Medical Systems, Inc. | 2000 | — |
| −7 | K042592 | Intemesh Silicone-Coated Sling and Surgical Mesh with Inhibizone, Model 72403304 | American Medical Systems, Inc. | 2004 | — |
| −6 | K053656 | Tyrx Antimicrobial Mesh | Tyrx Pharma, Inc. | 2006 | — |
| −5 | K063091 | Pivit CRM (Tyrx Antimicrobial Pacemaker Pouch), Model CMRM-0601 | Tyrx Pharma, Inc. | 2008 | 3 |
| −4 | K130943 | Aigis RX R PM/ Aigis RX R Icd | Tyrx, Inc. | 2013 | — |
| −3 | K180030 | TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial… | Medtronic, Inc. | 2018 | — |
| −2 | K192389 | TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial… | Medtronic, Inc. | 2020 | — |
| −1 | K233991 | CanGaroo RM Antibacterial Envelope | Elutia, Inc. | 2024 | — |
| 0 (this device) | K262406 | EluPro Antibiotic-Eluting BioEnvelope | Boston Scientific | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 2000 | 4 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 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 FTM? 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 FTM device
- #1 K233991 CanGaroo RM Antibacterial Envelopescore 13.5 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 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 |
|---|---|---|---|
| * | K233991 | CanGaroo RM Antibacterial EnvelopeSummary page 5…Class II Predicate Device The EluPro Antibiotic-Eluting BioEnvelope is substantially equivalent to the following device: • EluPro Antibiotic-Eluting BioEnvelope, K233991 Device Description The EluPro Antibiotic-Eluting BioEnvelope consists of decellularized, non-crosslinked, lyophilized extracellu… | 2024 |
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 33 years and passes through 9 companies; a new generation was cleared every 2.7 years on median.
- 2 of the 23 ancestors have a recall of any class.
How does its category compare?
All FTM devicesFTM Mesh, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · FTM
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FTM
29in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FTM
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FTM
232in 2025
MAUDE reports naming product code FTM, 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 | 9 | 104 | 7 | 60 |
| 2008 | 9 | 86 | 1 | 141 |
| 2009 | 7 | 86 | 0 | 476 |
| 2010 | 2 | — | 1 | 197 |
| 2011 | 6 | 100 | 8 | 288 |
| 2012 | 4 | 66 | 0 | 467 |
| 2013 | 4 | 123 | 0 | 3,351 |
| 2014 | 8 | 153 | 0 | 1,093 |
| 2015 | 4 | 316 | 0 | 977 |
| 2016 | 7 | 88 | 0 | 509 |
| 2017 | 9 | 147 | 0 | 529 |
| 2018 | 2 | — | 21 | 357 |
| 2019 | 6 | 107 | 4 | 418 |
| 2020 | 4 | 59 | 1 | 457 |
| 2021 | 4 | 61 | 1 | 369 |
| 2022 | 0 | — | 0 | 375 |
| 2023 | 2 | — | 1 | 485 |
| 2024 | 3 | 29 | 0 | 383 |
| 2025 | 1 | — | 0 | 232 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The EluPro Antibiotic-Eluting BioEnvelope is intended to securely hold a cardiac implantable electronic device or an implantable neurostimulator to create a stable environment when implanted in the body. The cardiac implantable electronic devices that may be used with the EluPro Antibiotic-Eluting BioEnvelope include pacemaker pulse generators, defibrillators, and other cardiac implantable electronic devices. The implantable neurostimulator devices that…
Read the full statement (115 words)
The EluPro Antibiotic-Eluting BioEnvelope is intended to securely hold a cardiac implantable electronic device or an implantable neurostimulator to create a stable environment when implanted in the body. The cardiac implantable electronic devices that may be used with the EluPro Antibiotic-Eluting BioEnvelope include pacemaker pulse generators, defibrillators, and other cardiac implantable electronic devices. The implantable neurostimulator devices that may be used with the EluPro Antibiotic-Eluting BioEnvelope include vagus nerve stimulators, spinal cord neuromodulators, deep brain stimulators, sacral nerve stimulators, and other neurostimulator devices.
The EluPro Antibiotic-Eluting BioEnvelope contains the antibiotics rifampin and minocycline, which have been shown in preclinical testing to reduce bacterial colonization on the envelope. Overall clinical benefit has not yet been evaluated.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K262406 · printed Nov 6, 2026
Cite this page
510(k) Report. “K262406: EluPro Antibiotic-Eluting BioEnvelope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K262406
Report an extraction error
Are you the manufacturer?
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