510(k) · Cleared
ClearedTYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope (large)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic, Inc. · FTL Mesh, Surgical, Polymeric
Cleared on Mar 27, 2020 as substantially equivalent to K180030 (Medtronic, Inc., 2018) after a 206-day review. Its family tree reaches back 10 generations to 1993. 2 later devices descend from it.
- Decided
- Mar 27, 2020
- Review
- 206 days
- Class
- Class II
- Product code
- FTL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K931386 (1993). 21 ancestors in all, the oldest K922916 (1992). 2 later devices descend from it, 1 citing it directly.
- Root · 10 generations backK931386 Hemashield Microvel/Woven Double Velour FabricMeadox Medicals, Div. Boston Scientific Corp. · 1993
- 6 generations between
- 3 generations backK063091 Pivit CRM (Tyrx Antimicrobial Pacemaker Pouch), Model CMRM-0601Tyrx Pharma, Inc. · 2008 · Recalled
- 2 generations backK130943 Aigis RX R PM/ Aigis RX R IcdTyrx, Inc. · 2013
- 1 generation backK180030 TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable…Medtronic, Inc. · 2018
- This deviceK192389 TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable…Medtronic, Inc. · 2020
- Descendant · cites it directly · 1 of its ownK233991 CanGaroo RM Antibacterial EnvelopeElutia, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK262406 EluPro Antibiotic-Eluting BioEnvelopeBoston Scientific · 2026
Show all 10 generations
- Root · 10 generations backK931386 Hemashield Microvel/Woven Double Velour FabricMeadox Medicals, Div. Boston Scientific Corp. · 1993
- 9 generations backK963611 Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek…Vascutek, Ltd. · 1996 · Recalled
- 8 generations backK972651 IN-SlingInfluence, Inc. · 1997
- 7 generations backK980482 Triangle SlingInfluence, Inc. · 1998
- 6 generations backK002721 Ams Triangle Silicone-Coated Sling and Surgical MeshAmerican Medical Systems, Inc. · 2000
- 5 generations backK042592 Intemesh Silicone-Coated Sling and Surgical Mesh with Inhibizone…American Medical Systems, Inc. · 2004
- 4 generations backK053656 Tyrx Antimicrobial MeshTyrx Pharma, Inc. · 2006
- 3 generations backK063091 Pivit CRM (Tyrx Antimicrobial Pacemaker Pouch), Model CMRM-0601Tyrx Pharma, Inc. · 2008 · Recalled
- 2 generations backK130943 Aigis RX R PM/ Aigis RX R IcdTyrx, Inc. · 2013
- 1 generation backK180030 TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable…Medtronic, Inc. · 2018
- This deviceK192389 TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable…Medtronic, Inc. · 2020
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K931386 | Hemashield Microvel/Woven Double Velour Fabric | Meadox Medicals, Div. Boston Scientific Corp. | 1993 | — |
| −9 | K963611 | Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek Gelsoft… | Vascutek, Ltd. | 1996 | 1 |
| −8 | K972651 | IN-Sling | Influence, Inc. | 1997 | — |
| −7 | K980482 | Triangle Sling | Influence, Inc. | 1998 | — |
| −6 | K002721 | Ams Triangle Silicone-Coated Sling and Surgical Mesh | American Medical Systems, Inc. | 2000 | — |
| −5 | K042592 | Intemesh Silicone-Coated Sling and Surgical Mesh with Inhibizone, Model 72403304 | American Medical Systems, Inc. | 2004 | — |
| −4 | K053656 | Tyrx Antimicrobial Mesh | Tyrx Pharma, Inc. | 2006 | — |
| −3 | K063091 | Pivit CRM (Tyrx Antimicrobial Pacemaker Pouch), Model CMRM-0601 | Tyrx Pharma, Inc. | 2008 | 3 |
| −2 | K130943 | Aigis RX R PM/ Aigis RX R Icd | Tyrx, Inc. | 2013 | — |
| −1 | K180030 | TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial… | Medtronic, Inc. | 2018 | — |
| 0 (this device) | K192389 | TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial… | Medtronic, Inc. | 2020 | — |
| +1 | K233991 | CanGaroo RM Antibacterial Envelope | Elutia, Inc. | 2024 | — |
| +2 | 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 |
|---|---|---|
| 2024 | 1 | 0 |
| 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 FTL? 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 FTL device
- #1 K220091 Poly-Tape/Infinity-Lock Soft Tissue…score 16.8 · 14 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 |
|---|---|---|---|
| * | K180030 | TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope…Summary page 4…: Shelf Life Extension TYRX™ Absorbable Antibacterial Envelope Surgical Mesh CFR 878.3300 FTL Class II Cardiovascular None TYRX™ Absorbable Antibacterial Envelope, K180030 TYRX Envelope Cardiac 12 Month Life Extension K192389 Medtronic 1-3 Device Description TYRX™ Absorbable Antib… | 2018 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K233991 | CanGaroo RM Antibacterial Envelope | 2024 | 1 |
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 27 years and passes through 7 companies; a new generation was cleared every 2.7 years on median.
- 2 of the 21 ancestors have a recall of any class.
- Of its descendants, K233991 (Elutia, Inc., 2024) has gone furthest, with 1 descendant of its own.
How does its category compare?
All FTL devicesFTL Mesh, Surgical, Polymeric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · FTL
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FTL
30in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FTL
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FTL
3,487in 2025
MAUDE reports naming product code FTL, 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 | 20 | 92 | 2 | 1,737 |
| 2008 | 23 | 114 | 1 | 1,569 |
| 2009 | 15 | 97 | 1 | 1,906 |
| 2010 | 18 | 132 | 12 | 2,175 |
| 2011 | 15 | 90 | 8 | 3,608 |
| 2012 | 12 | 213 | 2 | 14,700 |
| 2013 | 8 | 90 | 1 | 26,519 |
| 2014 | 11 | 70 | 3 | 2,683 |
| 2015 | 12 | 121 | 0 | 2,526 |
| 2016 | 3 | 186 | 0 | 2,417 |
| 2017 | 6 | 132 | 1 | 3,947 |
| 2018 | 12 | 105 | 1 | 11,893 |
| 2019 | 4 | 99 | 0 | 21,724 |
| 2020 | 5 | 138 | 1 | 18,819 |
| 2021 | 2 | — | 0 | 16,284 |
| 2022 | 6 | 195 | 0 | 11,439 |
| 2023 | 4 | 29 | 0 | 8,025 |
| 2024 | 2 | — | 0 | 8,565 |
| 2025 | 6 | 30 | 0 | 3,487 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The envelope is intended to hold a pacemaker pulse generator or defibrillator securely in order to provide a stable environment when implanted in the body. The envelope contains the antimicrobial agents rifampin and minocycline, which have been shown to reduce infection in an in vivo model of bacterial challenge following surgical implantation of the generator or defibrillator. The envelope is intended to be used in conjunction with pacemakers and implantable defibrillators.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K192389 · printed Nov 5, 2026
Cite this page
510(k) Report. “K192389: TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope (large).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K192389
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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