510(k) · Cleared
ClearedCanGaroo RM Antibacterial Envelope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Elutia, Inc. · FTM Mesh, Surgical
Cleared on Jun 14, 2024 as substantially equivalent to K192389 (Medtronic, Inc., 2020) after a 179-day review. Its family tree reaches back 11 generations to 1993. 1 later device descends from it.
- Decided
- Jun 14, 2024
- Review
- 179 days
- Class
- Class II
- Product code
- FTM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K931386 (1993). 22 ancestors in all, the oldest K922916 (1992). 1 later device descends from it, 1 citing it directly.
- Root · 11 generations backK931386 Hemashield Microvel/Woven Double Velour FabricMeadox Medicals, Div. Boston Scientific Corp. · 1993
- 7 generations between
- 3 generations backK130943 Aigis RX R PM/ Aigis RX R IcdTyrx, Inc. · 2013
- 2 generations backK180030 TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable…Medtronic, Inc. · 2018
- 1 generation backK192389 TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable…Medtronic, Inc. · 2020
- This deviceK233991 CanGaroo RM Antibacterial EnvelopeElutia, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK262406 EluPro Antibiotic-Eluting BioEnvelopeBoston Scientific · 2026
Show all 11 generations
- Root · 11 generations backK931386 Hemashield Microvel/Woven Double Velour FabricMeadox Medicals, Div. Boston Scientific Corp. · 1993
- 10 generations backK963611 Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek…Vascutek, Ltd. · 1996 · Recalled
- 9 generations backK972651 IN-SlingInfluence, Inc. · 1997
- 8 generations backK980482 Triangle SlingInfluence, Inc. · 1998
- 7 generations backK002721 Ams Triangle Silicone-Coated Sling and Surgical MeshAmerican Medical Systems, Inc. · 2000
- 6 generations backK042592 Intemesh Silicone-Coated Sling and Surgical Mesh with Inhibizone…American Medical Systems, Inc. · 2004
- 5 generations backK053656 Tyrx Antimicrobial MeshTyrx Pharma, Inc. · 2006
- 4 generations backK063091 Pivit CRM (Tyrx Antimicrobial Pacemaker Pouch), Model CMRM-0601Tyrx Pharma, Inc. · 2008 · Recalled
- 3 generations backK130943 Aigis RX R PM/ Aigis RX R IcdTyrx, Inc. · 2013
- 2 generations backK180030 TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable…Medtronic, Inc. · 2018
- 1 generation backK192389 TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable…Medtronic, Inc. · 2020
- This deviceK233991 CanGaroo RM Antibacterial EnvelopeElutia, Inc. · 2024
Most influential descendants
Showing 1 of 1 · See all- K262406EluPro Antibiotic-Eluting BioEnvelopeBoston Scientific · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K931386 | Hemashield Microvel/Woven Double Velour Fabric | Meadox Medicals, Div. Boston Scientific Corp. | 1993 | — |
| −10 | K963611 | Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek Gelsoft… | Vascutek, Ltd. | 1996 | 1 |
| −9 | K972651 | IN-Sling | Influence, Inc. | 1997 | — |
| −8 | K980482 | Triangle Sling | Influence, Inc. | 1998 | — |
| −7 | K002721 | Ams Triangle Silicone-Coated Sling and Surgical Mesh | American Medical Systems, Inc. | 2000 | — |
| −6 | K042592 | Intemesh Silicone-Coated Sling and Surgical Mesh with Inhibizone, Model 72403304 | American Medical Systems, Inc. | 2004 | — |
| −5 | K053656 | Tyrx Antimicrobial Mesh | Tyrx Pharma, Inc. | 2006 | — |
| −4 | K063091 | Pivit CRM (Tyrx Antimicrobial Pacemaker Pouch), Model CMRM-0601 | Tyrx Pharma, Inc. | 2008 | 3 |
| −3 | K130943 | Aigis RX R PM/ Aigis RX R Icd | Tyrx, Inc. | 2013 | — |
| −2 | K180030 | TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial… | Medtronic, Inc. | 2018 | — |
| −1 | K192389 | TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial… | Medtronic, Inc. | 2020 | — |
| 0 (this device) | K233991 | CanGaroo RM Antibacterial Envelope | Elutia, Inc. | 2024 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 K262406 EluPro Antibiotic-Eluting BioEnvelopescore 15.1 · 12 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 |
|---|---|---|---|
| * | K192389 | TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope…Summary page 4…Class II Predicate Device The CanGaroo® RM Antibacterial Envelope is substantially equivalent to the following device: • TYRX™ Absorbable Antibacterial Envelope, K192389 CanGaroo® (K201313), LUOFUCON® PHMB Alginate Dressing (K201016), and XenMatrix™ AB Surgical Graft (K162193) are reference device… | 2020 |
| † | K201313 | CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)… | 2020 |
| † | K201016 | LUOFUCON PHMB Alginate Dressing (Rx use), LUOFUCON PHMB Antibacterial Alginate Wound… | 2021 |
| † | K162193 | XenMatrix AB Surgical Graft | 2016 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K262406 | EluPro Antibiotic-Eluting BioEnvelope | 2026 | 0 |
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 31 years and passes through 8 companies; a new generation was cleared every 2.7 years on median.
- 2 of the 22 ancestors have a recall of any class.
- Of its descendants, K262406 (Boston Scientific, 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All FTM devicesFTM Mesh, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 CanGaroo® RM Antibacterial Envelope 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 CanGaroo RM Antibacterial Envelope include pacemaker pulse generators, defibrillators, and other cardiac implantable electronic devices. The implantable neurostimulator devices that may…
Read the full statement (119 words)
The CanGaroo® RM Antibacterial Envelope 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 CanGaroo RM Antibacterial Envelope include pacemaker pulse generators, defibrillators, and other cardiac implantable electronic devices. The implantable neurostimulator devices that may be used with the CanGaroo RM Antibacterial Envelope include vagus nerve stimulators, spinal cord neuromodulators, deep brain stimulators, sacral nerve stimulators, and other neurostimulator devices.
The CanGaroo RM Antibacterial Envelope 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/K233991 · printed Nov 4, 2026
Cite this page
510(k) Report. “K233991: CanGaroo RM Antibacterial Envelope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K233991
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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