510(k) Report

510(k) · Cleared

Cleared

Lsi Sew-Right R Series Suture Placement Device and Access Product Sew-Right SR-5R, Model 020999

K040232510(k) SpecialCleared Mar 1, 200428-day reviewClass II21 CFR 878.5000

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

Lsi Solutions · GAT Suture, Nonabsorbable, Synthetic, Polyethylene

Cleared on Mar 1, 2004 as substantially equivalent to K981531 (Lsi Solutions, 1998) after a 28-day review. Its family tree reaches back 2 generations to 1995. 6 later devices descend from it.

Decided
Mar 1, 2004
Review
28 days
Class
Class II
Product code
GAT
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K954853 (1995). 6 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2010: 1 descendant cleared2015: 2 descendants cleared2024: 1 descendant cleared2016: 1 descendant cleared2020: 1 descendant clearedK954853 · Auto Suture Suture Closure · United States Surgical, A Division of Tyco Healthc · 1995K981531 · Suture Placement Device and Accessories · Lsi Solutions · 19981995200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 3 descendants3 generations forward: 2 descendants K981531 · Suture Placement Device and Accessories · Lsi Solutions · 1998K954853 · Auto Suture Suture Closure · United States Surgical, A Division of Tyco Healthc · 19950
  1. Root · 2 generations backK954853 Auto Suture Suture ClosureUnited States Surgical, A Division of Tyco Healthc · 1995
  2. 1 generation backK981531 Suture Placement Device and AccessoriesLsi Solutions · 1998
  3. This deviceK040232 Lsi Sew-Right R Series Suture Placement Device and Access Product…Lsi Solutions · 2004
  4. Descendant · cites it directly · 5 of its ownK100593 Suture Placement Device and Accessories, Flexible Suture Placement…Lsi Solutions, Inc. · 2010
  5. Descendant · 2 generations on · 1 of its ownK160529 Pledgeted COR-SUTURE QUICK LOADLsi Soultions · 2016
  6. Descendant · 2 generations on · 1 of its ownK141206 Edwards Lifesciences Thruport Knotting SystemEdwards Lifesciences, LLC · 2015
  7. Descendant · 2 generations on · 0 of its ownK222783 MD Mattress Suture Placement DeviceLsi Solutions, Inc. · 2024
  8. Descendant · 3 generations on · 0 of its ownK203081 RAM COR-SUTURE QUCIK LOAD Surgical Suture, COR-SUTURE QUICK LOAD…Lsi Solutions · 2020

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2010: 12015: 22016: 12020: 12024: 1
2010high 2 (2015) · low 0 (2011)2026

Most influential descendants

Showing 5 of 6 · See all
  • K100593Suture Placement Device and Accessories, Flexible Suture Placement Device and…Lsi Solutions, Inc. · 2010 · cites it directly5descendants
  • K160529Pledgeted COR-SUTURE QUICK LOADLsi Soultions · 2016 · 2 generations on1descendant
  • K141206Edwards Lifesciences Thruport Knotting SystemEdwards Lifesciences, LLC · 2015 · 2 generations on1descendant
  • K222783MD Mattress Suture Placement DeviceLsi Solutions, Inc. · 2024 · 2 generations on0descendants
  • K203081RAM COR-SUTURE QUCIK LOAD Surgical Suture, COR-SUTURE QUICK LOAD Surgical SutureLsi Solutions · 2020 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K954853Auto Suture Suture ClosureUnited States Surgical, A Division of Tyco Healthc1995—
−1K981531Suture Placement Device and AccessoriesLsi Solutions1998—
0 (this device)K040232Lsi Sew-Right R Series Suture Placement Device and Access Product Sew-Right…Lsi Solutions2004—
+1K100593Suture Placement Device and Accessories, Flexible Suture Placement Device and…Lsi Solutions, Inc.2010—
+2K160529Pledgeted COR-SUTURE QUICK LOADLsi Soultions2016—
+2K141206Edwards Lifesciences Thruport Knotting SystemEdwards Lifesciences, LLC2015—
+2K222783MD Mattress Suture Placement DeviceLsi Solutions, Inc.2024—
+3K203081RAM COR-SUTURE QUCIK LOAD Surgical Suture, COR-SUTURE QUICK LOAD Surgical SutureLsi Solutions2020—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201520
201610
202010
202410
FIG. 1 — Lineage of K040232, 1995–2024Source: 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 GAT? 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 GAT device

  1. #1 K230311 HyperSuturescore 20.2 · 7 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
*K981531Suture Placement Device and Accessories
Summary page 1
…Accessories Product Classification: 21 CFR 878.4800; Manual Surgical Instrumentfor General Use Predicate Device: LSI Suture Placement Device and Accessories (K98 153 1) Description: The LSI "R" Series Suturing Device and Accessories Product, like the predicate, is i…
Lsi Solutions1998—

Also cleared against K981531: 4 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
K100593Suture Placement Device and Accessories, Flexible Suture Placement Device and…Lsi Solutions, Inc.20105

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 9 years and passes through 2 companies; a new generation was cleared every 5.6 years on median.
  • None of the 2 ancestors has a recall.
  • Of its descendants, K100593 (Lsi Solutions, Inc., 2010) has gone furthest, with 5 descendants of its own.
  • 4 other devices also cite its predicate K981531.

How does its category compare?

All GAT devices

GAT Suture, Nonabsorbable, Synthetic, Polyethylene: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GAT

5in 2025

2007: 62008: 42009: 92010: 112011: 12012: 62013: 42014: 42015: 72016: 102017: 62018: 62019: 42020: 52021: 42022: 52023: 82024: 32025: 52026 (partial year): 5
2007high 11 (2010) · low 1 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GAT

30in 2025

2007: 40 days median2008: 93 days median2009: 57 days median2010: 27 days median2012: 61 days median2013: 123 days median2014: 45 days median2015: 125 days median2016: 139 days median2017: 57 days median2018: 95 days median2019: 79 days median2020: 201 days median2021: 92 days median2022: 109 days median2023: 220 days median2024: 140 days median2025: 30 days median2026 (partial year): 83 days median
2007high 220 (2023) · low 27 (2010)2026

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

Recalls per year · GAT

1in 2011

2007: 12010: 32011: 1
2007high 3 (2010) · low 0 (2008)2026

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

Adverse event reports per year · GAT

2,956in 2025

2007: 152008: 152009: 552010: 792011: 972012: 2532013: 2102014: 1652015: 6262016: 6882017: 1,1042018: 1,4532019: 1,2512020: 1,2202021: 1,6432022: 1,4192023: 2,0382024: 2,5972025: 2,956
2007high 2,956 (2025) · low 15 (2007)2025

MAUDE reports naming product code GAT, 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
2007640115
2008493015
2009957055
20101127379
20111—197
20126610253
201341230210
20144450165
201571250626
2016101390688
201765701,104
201869501,453
201947901,251
2020520101,220
202149201,643
2022510901,419
2023822002,038
2024314002,597
202553002,956
20265830—

What is it indicated for?

Approximation of soft tissue

Indications for use as stated in the FDA summary.

Also cleared against K981531

4 other devices cite the same predicate.

  • K202551Cor-Knot MicroLsi Solutions, Inc. · 2021
  • K123811StitchkitOrigami Surgical, LLC · 2013
  • K100593Suture Placement Device and Accessories, Flexible Suture Placement Device and Accessories, Lsi R Series…Lsi Solutions, Inc. · 2010
  • K063462Neatstitch Neatclose Suturing DeviceNeat Stitch, Ltd. · 2007

More from Lsi Solutions

8 FDA decisions under this applicant name. See the company

  • K203081RAM COR-SUTURE QUCIK LOAD Surgical Suture, COR-SUTURE QUICK LOAD Surgical SutureLsi Solutions · 2020
  • K163639LS-5 ePTFE SutureLsi Solutions · 2017
  • K031443Lsi Solutions Suture Quick Load ProductsLsi Solutions · 2003
  • K024301Lsi Endoscopic External Accessory Channel and Accessories ProductLsi Solutions · 2003
  • K011016Lsi Solutions Flexible Suture Placement Device and Accessories ProductLsi Solutions · 20011 recall

Recent decisions in GAT

The GAT category page

  • K253910Stitch - Suture Wires and TapesGM Dos Reis Industria e Comercio Ltda. · 2026
  • K261021EasyWhip FamilyWinter Innovations, Inc. · 2026
  • K260775Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™Teleflex Medical, LLC · 2026
  • K254275HyperSuture All Green Extension LineThreadstone, LLC · 2026
  • K254188Meniscus VersaflexGM Dos Reis Industria e Comercio Ltda. · 2026

https://510kreport.com/device/K040232 · printed Nov 3, 2026

Cite this page

510(k) Report. “K040232: Lsi Sew-Right R Series Suture Placement Device and Access Product Sew-Right SR-5R, Model 020999.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K040232

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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