510(k) Report

510(k) · Cleared

Cleared

Alyte Y-Mesh Graft

K101722510(k) TraditionalCleared Apr 1, 2011287-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

C.R. Bard, Inc. · OTO Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed

Cleared on Apr 1, 2011 as substantially equivalent to K090739 (C.R. Bard, Inc., 2009) and 2 other predicates after a 287-day review. Its family tree reaches back 9 generations to 1993. 8 later devices descend from it.

Decided
Apr 1, 2011
Review
287 days
Class
Class II
Product code
OTO
Recalls
None
Predicates
3

Its longest line of descent runs back 9 generations to K931386 (1993). 23 ancestors in all, the oldest K905655 (1990). 8 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2006: 2 other ancestors2004: 1 other ancestor2002: 2 other ancestors2000: 1 other ancestor1998: 2 other ancestors1996: 2 other ancestors1992: 1 other ancestor1990: 1 other ancestor2001: 1 other ancestor1994: 1 other ancestor2012: 3 descendants cleared2013: 2 descendants cleared2015: 1 descendant cleared2014: 1 descendant cleared2018: 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. · 1998×2: 2 generations cleared close together, K002721 (2000), K010931 (2001) ×2: 2 generations cleared close together, K033636 (2003), K040521 (2004) K090739 · Bard Sacrocolpopexy Graft · C.R. Bard, Inc. · 20091990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 1 other ancestor3 generations back: 6 other ancestors4 generations back: 2 other ancestors5 generations back: 4 other ancestors 1 generation forward: 3 descendants2 generations forward: 3 descendants3 generations forward: 1 descendant4 generations forward: 1 descendant K090739 · Bard Sacrocolpopexy Graft · C.R. Bard, Inc. · 2009K040521 · Modification to Ams Large Pore Polypropylene Mesh · American Medical Systems, Inc. · 2004K033636 · Ams Large Pore Polypropylene Mesh · American Medical Systems, Inc. · 2003K010931 · Ams Sacral Colpopexy Sling, Model 72403501 · American Medical Systems, Inc. · 2001K002721 · 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
  1. Root · 9 generations backK931386 Hemashield Microvel/Woven Double Velour FabricMeadox Medicals, Div. Boston Scientific Corp. · 1993
  2. 5 generations between
  3. 3 generations backK033636 Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2003
  4. 2 generations backK040521 Modification to Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2004
  5. 1 generation backK090739 Bard Sacrocolpopexy GraftC.R. Bard, Inc. · 2009
  6. This deviceK101722 Alyte Y-Mesh GraftC.R. Bard, Inc. · 2011
  7. Descendant · cites it directly · 6 of its ownK112322 Restorelle Polypropylene Y MeshColoplast A/S · 2012
  8. Descendant · 2 generations on · 2 of its ownK123914 Restorelle Y ContourColoplast A/S · 2013
  9. Descendant · 3 generations on · 1 of its ownK140116 Restorelle Y Contour MeshColoplast A/S · 2014
  10. Descendant · cites it directly · 1 of its ownK123028 Vertessa Lite 10 X20CM, Vertessa Lite 11 X 30CM, Vertessa Lite Y-MeshCaldera Medical, Inc. · 2013
  11. Descendant · 4 generations on · 0 of its ownK173501 Meridian Vaginal Positioning System (VPS)Coloplast · 2018
Show all 9 generations
  1. Root · 9 generations backK931386 Hemashield Microvel/Woven Double Velour FabricMeadox Medicals, Div. Boston Scientific Corp. · 1993
  2. 8 generations backK963611 Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek…Vascutek, Ltd. · 1996 · Recalled
  3. 7 generations backK972651 IN-SlingInfluence, Inc. · 1997
  4. 6 generations backK980482 Triangle SlingInfluence, Inc. · 1998
  5. 5 generations backK002721 Ams Triangle Silicone-Coated Sling and Surgical MeshAmerican Medical Systems, Inc. · 2000
  6. 4 generations backK010931 Ams Sacral Colpopexy Sling, Model 72403501American Medical Systems, Inc. · 2001
  7. 3 generations backK033636 Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2003
  8. 2 generations backK040521 Modification to Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2004
  9. 1 generation backK090739 Bard Sacrocolpopexy GraftC.R. Bard, Inc. · 2009
  10. This deviceK101722 Alyte Y-Mesh GraftC.R. Bard, Inc. · 2011

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2012: 32013: 22014: 12015: 12018: 1
2012high 3 (2012) · low 0 (2016)2026

Most influential descendants

Showing 5 of 8 · See all
  • K112322Restorelle Polypropylene Y MeshColoplast A/S · 2012 · cites it directly6descendants
  • K123914Restorelle Y ContourColoplast A/S · 2013 · 2 generations on2descendants
  • K140116Restorelle Y Contour MeshColoplast A/S · 2014 · 3 generations on1descendant
  • K123028Vertessa Lite 10 X20CM, Vertessa Lite 11 X 30CM, Vertessa Lite Y-MeshCaldera Medical, Inc. · 2013 · cites it directly1descendant
  • K173501Meridian Vaginal Positioning System (VPS)Coloplast · 2018 · 4 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−9K931386Hemashield Microvel/Woven Double Velour FabricMeadox Medicals, Div. Boston Scientific Corp.1993—
−8K963611Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek Gelsoft…Vascutek, Ltd.19961
−7K972651IN-SlingInfluence, Inc.1997—
−6K980482Triangle SlingInfluence, Inc.1998—
−5K002721Ams Triangle Silicone-Coated Sling and Surgical MeshAmerican Medical Systems, Inc.2000—
−4K010931Ams Sacral Colpopexy Sling, Model 72403501American Medical Systems, Inc.2001—
−3K033636Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc.2003—
−2K040521Modification to Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc.2004—
−1K090739Bard Sacrocolpopexy GraftC.R. Bard, Inc.2009—
0 (this device)K101722Alyte Y-Mesh GraftC.R. Bard, Inc.2011—
+1K112322Restorelle Polypropylene Y MeshColoplast A/S2012—
+2K123914Restorelle Y ContourColoplast A/S2013—
+3K140116Restorelle Y Contour MeshColoplast A/S2014—
+1K123028Vertessa Lite 10 X20CM, Vertessa Lite 11 X 30CM, Vertessa Lite Y-MeshCaldera Medical, Inc.2013—
+4K173501Meridian Vaginal Positioning System (VPS)Coloplast2018—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199010
199210
199410
199620
199820
200010
200110
200220
200410
200620

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201230
201320
201410
201510
201810
FIG. 1 — Lineage of K101722, 1993–2018Source: 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 OTO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against? (3)

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
*K090739Bard Sacrocolpopexy Graft
Summary page 1
…h, Surgical, Gynocological, For Apical Vaginal Prolapse, Transabdominally Placed Predicate Device(s): ALYTE TM Y-Mesh Graft (BARD Graft), CR BARD, K090739 Caldera Mesh, Caldera Medical, K060004 AMS Sacral Colpopexy Sling, American Medical Sys…
C.R. Bard, Inc.2009—
*K060004Caldera Mesh
Summary page 1
…Transabdominally Placed Predicate Device(s): ALYTE TM Y-Mesh Graft (BARD Graft), CR BARD, K090739 Caldera Mesh, Caldera Medical, K060004 AMS Sacral Colpopexy Sling, American Medical Systems, K010931 Device Description: The ALYTETM Y-Mesh Graft…
Caldera Medical, Inc.2006—
*K010931Ams Sacral Colpopexy Sling, Model 72403501
Summary page 1
…aft (BARD Graft), CR BARD, K090739 Caldera Mesh, Caldera Medical, K060004 AMS Sacral Colpopexy Sling, American Medical Systems, K010931 Device Description: The ALYTETM Y-Mesh Graft is composed of lightweight/ultralightweight, non-absorbable, monofilament, polyprop…
American Medical Systems, Inc.2001—

What descends from it? (8)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K112322Restorelle Polypropylene Y MeshColoplast A/S20126
K123028Vertessa Lite 10 X20CM, Vertessa Lite 11 X 30CM, Vertessa Lite Y-MeshCaldera Medical, Inc.20131
K113205Artisyn Y-Shaped MeshETHICON, Inc.20120

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 18 years and passes through 5 companies; a new generation was cleared every 1.4 years on median.
  • 4 of the 23 ancestors have a recall of any class.
  • Of its descendants, K112322 (Coloplast A/S, 2012) has gone furthest, with 6 descendants of its own.

How does its category compare?

All OTO devices

OTO Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · OTO

1in 2017

2009: 12011: 12012: 72013: 42014: 12015: 22017: 1
2007high 7 (2012) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OTO

95in 2013

2012: 101 days median2013: 95 days median
2007high 101 (2012) · low 95 (2013)2026

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

Recalls per year · OTO

No recall names OTO since 2007.

Adverse event reports per year · OTO

79in 2025

2011: 72012: 1602013: 2,2722014: 2672015: 4482016: 1562017: 752018: 1452019: 3472020: 1532021: 2922022: 1122023: 1012024: 1132025: 79
2007high 2,272 (2013) · low 0 (2007)2025

MAUDE reports naming product code OTO, 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
20070—00
20080—00
20091—00
20100—00
20111—07
201271010160
201349502,272
20141—0267
20152—0448
20160—0156
20171—075
20180—0145
20190—0347
20200—0153
20210—0292
20220—0112
20230—0101
20240—0113
20250—079
20260—0—

What is it indicated for?

The ALYTE TM Y-Mesh Graft is indicated for use as a bridging material for

sacrocolposuspension /sacrocolpopexy (laparotomy or laparoscopic approach)

where surgical treatment for vaginal vault prolapse is warranted.

Indications for use as stated in the FDA summary.

More from C.R. Bard, Inc.

711 FDA decisions under this applicant name. See the company

  • P800002/S036Avitene Microfibrillar Collagen Hemostat (MCH) Non-Woven Web WebberC.R. Bard, Inc. · 2026
  • P800002/S035Avitene Microfibrillar Collagen Hemostat (MCH) Non-Woven WebC.R. Bard, Inc. · 2026
  • K253514Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore Esophageal-Nasogastric…C.R. Bard, Inc. · 2026
  • P170042/S015Covera™ Vascular Covered StentC.R. Bard, Inc. · 2026
  • K254076BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter KitC.R. Bard, Inc. · 2026

Recent decisions in OTO

The OTO category page

  • K171271Polyform Synthetic MeshBoston Scientific Corporation · 2017
  • K150023Vertessa Lite Y-MeshCaldera Medical, Inc. · 2015
  • K150016Vertessa LiteCaldera Medical, Inc. · 2015
  • K140116Restorelle Y Contour MeshColoplast A/S · 2014
  • K132061Restorelle M, Restorelle XLColoplast Corp. · 2013

https://510kreport.com/device/K101722 · printed Nov 4, 2026

Cite this page

510(k) Report. “K101722: Alyte Y-Mesh Graft.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K101722

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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