510(k) Report

510(k) · Cleared

Cleared

Aigis RX N Medium; Aigis RX N Large

K131007510(k) TraditionalCleared Jul 10, 201390-day reviewClass II21 CFR 878.3300

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Tyrx, Inc. · FTL Mesh, Surgical, Polymeric

Cleared on Jul 10, 2013 as substantially equivalent to K063091 (Tyrx Pharma, Inc., 2008) after a 90-day review. Its family tree reaches back 8 generations to 1993. 6 later devices descend from it.

Decided
Jul 10, 2013
Review
90 days
Class
Class II
Product code
FTL
Recalls
None
Predicates
1

Its longest line of descent runs back 8 generations to K931386 (1993). 19 ancestors in all, the oldest K922916 (1992). 6 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 1 other ancestor2005: 1 other ancestor2000: 4 other ancestors2004: 1 other ancestor1998: 1 other ancestor1996: 2 other ancestors1992: 1 other ancestor2013: 1 descendant cleared2014: 1 descendant cleared2015: 2 descendants cleared2018: 1 descendant cleared2020: 1 descendant clearedK931386 · Hemashield Microvel/Woven Double Velour Fabric · Meadox Medicals, Div. Boston Scientific Corp. · 1993K963611 · Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek Gelsoft Patch,Vascutek Thin Wall Carotid Patch · Vascutek, Ltd. · 1996 · recalledK972651 · IN-Sling · Influence, Inc. · 1997K980482 · Triangle Sling · Influence, Inc. · 1998K002721 · Ams Triangle Silicone-Coated Sling and Surgical Mesh · American Medical Systems, Inc. · 2000K042592 · Intemesh Silicone-Coated Sling and Surgical Mesh with Inhibizone, Model 72403304 · American Medical Systems, Inc. · 2004K053656 · Tyrx Antimicrobial Mesh · Tyrx Pharma, Inc. · 2006K063091 · Pivit CRM (Tyrx Antimicrobial Pacemaker Pouch), Model CMRM-0601 · Tyrx Pharma, Inc. · 2008 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 1 other ancestor3 generations back: 2 other ancestors4 generations back: 4 other ancestors5 generations back: 3 other ancestors7 generations back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 2 descendants3 generations forward: 1 descendant4 generations forward: 1 descendant5 generations forward: 1 descendant K063091 · Pivit CRM (Tyrx Antimicrobial Pacemaker Pouch), Model CMRM-0601 · Tyrx Pharma, Inc. · 2008 · recalledK053656 · Tyrx Antimicrobial Mesh · Tyrx Pharma, Inc. · 2006K042592 · Intemesh Silicone-Coated Sling and Surgical Mesh with Inhibizone, Model 72403304 · American Medical Systems, Inc. · 2004K002721 · Ams Triangle Silicone-Coated Sling and Surgical Mesh · American Medical Systems, Inc. · 2000K980482 · Triangle Sling · Influence, Inc. · 1998K972651 · IN-Sling · Influence, Inc. · 1997K963611 · Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek Gelsoft Patch,Vascutek Thin Wall Carotid Patch · Vascutek, Ltd. · 1996 · recalledK931386 · Hemashield Microvel/Woven Double Velour Fabric · Meadox Medicals, Div. Boston Scientific Corp. · 1993−50+5
  1. Root · 8 generations backK931386 Hemashield Microvel/Woven Double Velour FabricMeadox Medicals, Div. Boston Scientific Corp. · 1993
  2. 7 generations backK963611 Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek…Vascutek, Ltd. · 1996 · Recalled
  3. 6 generations backK972651 IN-SlingInfluence, Inc. · 1997
  4. 5 generations backK980482 Triangle SlingInfluence, Inc. · 1998
  5. 4 generations backK002721 Ams Triangle Silicone-Coated Sling and Surgical MeshAmerican Medical Systems, Inc. · 2000
  6. 3 generations backK042592 Intemesh Silicone-Coated Sling and Surgical Mesh with Inhibizone…American Medical Systems, Inc. · 2004
  7. 2 generations backK053656 Tyrx Antimicrobial MeshTyrx Pharma, Inc. · 2006
  8. 1 generation backK063091 Pivit CRM (Tyrx Antimicrobial Pacemaker Pouch), Model CMRM-0601Tyrx Pharma, Inc. · 2008 · Recalled
  9. This deviceK131007 Aigis RX N Medium; Aigis RX N LargeTyrx, Inc. · 2013
  10. Descendant · cites it directly · 5 of its ownK132699 Aigis RX N (Medium), Aigis RX N (Large)Tyrx, Inc. · 2013
  11. Descendant · 2 generations on · 4 of its ownK142611 TYRX Neuro Absorbable Antibacterial EnvelopeMedtronic Tyrx, Inc. · 2014
  12. Descendant · 3 generations on · 3 of its ownK150291 TYRX Neuro Absorbable Antibacterial EnvelopeMedtronic Tyrx, Inc. · 2015
  13. Descendant · 4 generations on · 1 of its ownK180122 TYRX Neuro Absorbable Antibacterial Envelope (medium); TYRX Neuro…Medtronic, Inc. · 2018
  14. Descendant · 5 generations on · 0 of its ownK192636 TYRX Neuro Absorbable Antibacterial Envelope (Medium), TYRX Neuro…Medtronic, Inc. · 2020

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2013: 12014: 12015: 22018: 12020: 1
2013high 2 (2015) · low 0 (2016)2026

Most influential descendants

Showing 5 of 6 · See all
  • K132699Aigis RX N (Medium), Aigis RX N (Large)Tyrx, Inc. · 2013 · cites it directly5descendants
  • K142611TYRX Neuro Absorbable Antibacterial EnvelopeMedtronic Tyrx, Inc. · 2014 · 2 generations on4descendants
  • K150291TYRX Neuro Absorbable Antibacterial EnvelopeMedtronic Tyrx, Inc. · 2015 · 3 generations on3descendants
  • K180122TYRX Neuro Absorbable Antibacterial Envelope (medium); TYRX Neuro Absorbable…Medtronic, Inc. · 2018 · 4 generations on1descendant
  • K192636TYRX Neuro Absorbable Antibacterial Envelope (Medium), TYRX Neuro Absorbable…Medtronic, Inc. · 2020 · 5 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−8K931386Hemashield Microvel/Woven Double Velour FabricMeadox Medicals, Div. Boston Scientific Corp.1993—
−7K963611Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek Gelsoft…Vascutek, Ltd.19961
−6K972651IN-SlingInfluence, Inc.1997—
−5K980482Triangle SlingInfluence, Inc.1998—
−4K002721Ams Triangle Silicone-Coated Sling and Surgical MeshAmerican Medical Systems, Inc.2000—
−3K042592Intemesh Silicone-Coated Sling and Surgical Mesh with Inhibizone, Model 72403304American Medical Systems, Inc.2004—
−2K053656Tyrx Antimicrobial MeshTyrx Pharma, Inc.2006—
−1K063091Pivit CRM (Tyrx Antimicrobial Pacemaker Pouch), Model CMRM-0601Tyrx Pharma, Inc.20083
0 (this device)K131007Aigis RX N Medium; Aigis RX N LargeTyrx, Inc.2013—
+1K132699Aigis RX N (Medium), Aigis RX N (Large)Tyrx, Inc.2013—
+2K142611TYRX Neuro Absorbable Antibacterial EnvelopeMedtronic Tyrx, Inc.2014—
+3K150291TYRX Neuro Absorbable Antibacterial EnvelopeMedtronic Tyrx, Inc.2015—
+4K180122TYRX Neuro Absorbable Antibacterial Envelope (medium); TYRX Neuro Absorbable…Medtronic, Inc.2018—
+5K192636TYRX Neuro Absorbable Antibacterial Envelope (Medium), TYRX Neuro Absorbable…Medtronic, Inc.2020—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199210
199620
199810
200040
200110
200410
200510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
201410
201520
201810
202010
FIG. 1 — Lineage of K131007, 1993–2020Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K220091 Poly-Tape/Infinity-Lock Soft Tissue…score 16.8 · 14 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K063091Pivit CRM (Tyrx Antimicrobial Pacemaker Pouch), Model CMRM-0601
Summary page 1
…gical Mesh, Class 11 PROCODE: FTL Predicate Device Name and 510(k) Number AIGISRx®& (K06309 1) Device Description: AIGISRx® N is a dual component (resorbable and non-resorbable) sterile prosthesis designed t…
Tyrx Pharma, Inc.20083

Also cleared against K063091: 2 other devices →

What descends from it? (6)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K132699Aigis RX N (Medium), Aigis RX N (Large)Tyrx, Inc.20135

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 20 years and passes through 6 companies; a new generation was cleared every 2.7 years on median.
  • 2 of the 19 ancestors have a recall of any class.
  • Of its descendants, K132699 (Tyrx, Inc., 2013) has gone furthest, with 5 descendants of its own.
  • 2 other devices also cite its predicate K063091.

How does its category compare?

All FTL devices

FTL Mesh, Surgical, Polymeric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

FDA decisions per year · FTL

6in 2025

2007: 202008: 232009: 152010: 182011: 152012: 122013: 82014: 112015: 122016: 32017: 62018: 122019: 42020: 52021: 22022: 62023: 42024: 22025: 62026 (partial year): 2
2007high 23 (2008) · low 2 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FTL

30in 2025

2007: 92 days median2008: 114 days median2009: 97 days median2010: 132 days median2011: 90 days median2012: 213 days median2013: 90 days median2014: 70 days median2015: 121 days median2016: 186 days median2017: 132 days median2018: 105 days median2019: 99 days median2020: 138 days median2022: 195 days median2023: 29 days median2025: 30 days median
2007high 213 (2012) · low 29 (2023)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FTL

1in 2020

2007: 22008: 12009: 12010: 122011: 82012: 22013: 12014: 32017: 12018: 12020: 1
2007high 12 (2010) · low 0 (2015)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FTL

3,487in 2025

2007: 1,7372008: 1,5692009: 1,9062010: 2,1752011: 3,6082012: 14,7002013: 26,5192014: 2,6832015: 2,5262016: 2,4172017: 3,9472018: 11,8932019: 21,7242020: 18,8192021: 16,2842022: 11,4392023: 8,0252024: 8,5652025: 3,487
2007high 26,519 (2013) · low 1,569 (2008)2025

MAUDE reports naming product code FTL, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007209221,737
20082311411,569
2009159711,906
201018132122,175
2011159083,608
201212213214,700
2013890126,519
2014117032,683
20151212102,526
2016318602,417
2017613213,947
201812105111,893
2019499021,724
20205138118,819
20212—016,284
20226195011,439
202342908,025
20242—08,565
202563003,487
20262—0—

What is it indicated for?

AIGISRx® N is intended to hold a vagus nerve stimulator securely in order to create a stable environment when implanted in the body. AIGISRx® N 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 a pulse generator or defibrillator. This device is only intended to be used in conjunction with vagus nerve stimulators implanted in the infraclavicular fossa.

Indications for use as stated in the FDA summary.

Also cleared against K063091

2 other devices cite the same predicate.

  • K140306Cormatrix Protect Ecm EnvelopeCormatrix Cardiovascular, Inc. · 20142 recalls
  • K130943Aigis RX R PM/ Aigis RX R IcdTyrx, Inc. · 2013

More from Tyrx, Inc.

5 FDA decisions under this applicant name. See the company

  • K152678TYRX Neuro Antibacterial EnvelopeTyrx, Inc. · 2015
  • K132699Aigis RX N (Medium), Aigis RX N (Large)Tyrx, Inc. · 2013
  • K130943Aigis RX R PM/ Aigis RX R IcdTyrx, Inc. · 2013
  • K093524Pivit a/B ST and Pivit a/B ST-RTyrx, Inc. · 2010

Recent decisions in FTL

The FTL category page

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  • K253125Parietene™ Flat Sheet MeshMedtronic - Sofradim Production · 2025
  • K251955Onflex™ MeshDavol Inc., Subsidiary of C. R. Bard, Inc. · 2025
  • K251557Bard® Mesh; Bard® Mesh Pre-ShapedDavol, Inc. · 2025

https://510kreport.com/device/K131007 · printed Nov 6, 2026

Cite this page

510(k) Report. “K131007: Aigis RX N Medium; Aigis RX N Large.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131007

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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