510(k) Report

510(k) · Cleared

Cleared

Cabs'air

K072962510(k) TraditionalCleared Jun 26, 2008251-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

Cousin Biotech Sas · FTL Mesh, Surgical, Polymeric

Cleared on Jun 26, 2008 after a 251-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 22 later devices descend from it.

Decided
Jun 26, 2008
Review
251 days
Class
Class II
Product code
FTL
Recalls
None
Predicates
0

22 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2011: 2 descendants cleared2010: 3 descendants cleared2018: 3 descendants cleared2013: 3 descendants cleared2012: 1 descendant cleared2014: 2 descendants cleared2022: 2 descendants cleared2015: 2 descendants cleared2024: 1 descendant cleared2017: 1 descendant cleared2025: 1 descendant cleared2026: 1 descendant cleared20052010201520202025
  1. This deviceK072962 Cabs'airCousin Biotech Sas · 2008
  2. Descendant · cites it directly · 12 of its ownK110663 Pairetex Optimized Composite Mesh (Pco-FX Refrences)Sofradim Production · 2011
  3. Descendant · 2 generations on · 10 of its ownK131969 Symbotex (TM) Composite MeshSofradim Production · 2013
  4. Descendant · cites it directly · 7 of its ownK092726 Mesh GPS - Large, Small, SM, SM SmallSurgical Structures, Ltd. · 2010
  5. Descendant · 2 generations on · 6 of its ownK102766 Composix L/P Mesh with Echo PS Positioning SystemC.R. Bard, Inc. · 2010 · Recalled
  6. Descendant · 3 generations on · 5 of its ownK142908 Parietex Monofilament Polyester Mesh (new name: Parietex Lightweight…Sofradim Production · 2014 · Recalled

Showing 5 of 22 descendants. See all descendants

Descendants cleared per year

2010: 32011: 22012: 12013: 32014: 22015: 22017: 12018: 32022: 22024: 12025: 12026: 1
2010high 3 (2010) · low 0 (2016)2026

Most influential descendants

Showing 5 of 22 · See all
  • K110663Pairetex Optimized Composite Mesh (Pco-FX Refrences)Sofradim Production · 2011 · cites it directly12descendants
  • K131969Symbotex (TM) Composite MeshSofradim Production · 2013 · 2 generations on10descendants
  • K092726Mesh GPS - Large, Small, SM, SM SmallSurgical Structures, Ltd. · 2010 · cites it directly7descendants
  • K102766Composix L/P Mesh with Echo PS Positioning SystemC.R. Bard, Inc. · 2010 · 2 generations on6descendants
  • K142908Parietex Monofilament Polyester Mesh (new name: Parietex Lightweight Mesh), Parietex…Sofradim Production · 2014 · 3 generations on5descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K072962Cabs'airCousin Biotech Sas2008—
+1K110663Pairetex Optimized Composite Mesh (Pco-FX Refrences)Sofradim Production2011—
+2K131969Symbotex (TM) Composite MeshSofradim Production2013—
+1K092726Mesh GPS - Large, Small, SM, SM SmallSurgical Structures, Ltd.2010—
+2K102766Composix L/P Mesh with Echo PS Positioning SystemC.R. Bard, Inc.20102
+3K142908Parietex Monofilament Polyester Mesh (new name: Parietex Lightweight Mesh)…Sofradim Production20141

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201030
201120
201210
201330
201420
201520
201710
201830
202220
202410
202510
202610
FIG. 1 — Lineage of K072962, 2008–2026Source: 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), 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
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (22)

See all 22

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

NumberDeviceApplicantDecidedDescendants
K110663Pairetex Optimized Composite Mesh (Pco-FX Refrences)Sofradim Production201112
K092726Mesh GPS - Large, Small, SM, SM SmallSurgical Structures, Ltd.20107
K093196Biomesh CA.B.S. 'Air Composite, Models: CABST1R05T, CABSAIRC7, CABSAIRC09Cousin Biotech Sas20100

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?

  • Of its descendants, K110663 (Sofradim Production, 2011) has gone furthest, with 12 descendants of its own.

How does its category compare?

All FTL devices

FTL Mesh, Surgical, Polymeric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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—
Cite this page

510(k) Report. “K072962: Cabs'air.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072962

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026