510(k) Report

510(k) · Cleared

Cleared

Lsi Solutions Suture Quick Load Products

K031443510(k) AbbreviatedCleared Jun 18, 200343-day reviewClass II21 CFR 878.4840

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

Lsi Solutions · NEW Suture, Surgical, Absorbable, Polydioxanone

Cleared on Jun 18, 2003 as substantially equivalent to K930738 (Deknatel, Inc., 1994) and 2 other predicates after a 43-day review. Its family tree reaches back 1 generation to 1994. 7 later devices descend from it.

Decided
Jun 18, 2003
Review
43 days
Class
Class II
Product code
NEW
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K930738 (1994). 3 ancestors in all. 7 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 1 other ancestor1999: 1 other ancestor2010: 1 descendant cleared2020: 2 descendants cleared2015: 2 descendants cleared2024: 1 descendant cleared2016: 1 descendant clearedK930738 · Surgical Sutures, PGL, Gut, Deklene, Opthamend Etc · Deknatel, Inc. · 1994 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 2 descendants2 generations forward: 3 descendants3 generations forward: 2 descendants K930738 · Surgical Sutures, PGL, Gut, Deklene, Opthamend Etc · Deknatel, Inc. · 1994 · recalled0
  1. Root · 1 generation backK930738 Surgical Sutures, PGL, Gut, Deklene, Opthamend EtcDeknatel, Inc. · 1994 · Recalled
  2. This deviceK031443 Lsi Solutions Suture Quick Load ProductsLsi Solutions · 2003
  3. Descendant · cites it directly · 5 of its ownK100593 Suture Placement Device and Accessories, Flexible Suture Placement…Lsi Solutions, Inc. · 2010
  4. Descendant · 2 generations on · 1 of its ownK160529 Pledgeted COR-SUTURE QUICK LOADLsi Soultions · 2016
  5. Descendant · 2 generations on · 1 of its ownK141206 Edwards Lifesciences Thruport Knotting SystemEdwards Lifesciences, LLC · 2015
  6. Descendant · 2 generations on · 0 of its ownK222783 MD Mattress Suture Placement DeviceLsi Solutions, Inc. · 2024
  7. Descendant · cites it directly · 0 of its ownK203120 RD QUICK LOAD SUTURE, 0 Polyester, RD QUICK LOAD SUTURE, 2-0…Lsi Solutions, Inc. · 2020

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2010: 12015: 22016: 12020: 22024: 1
2010high 2 (2015) · low 0 (2011)2026

Most influential descendants

Showing 5 of 7 · 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
  • K203120RD QUICK LOAD SUTURE, 0 Polyester, RD QUICK LOAD SUTURE, 2-0 Polyester, RD QUCIK LOAD…Lsi Solutions, Inc. · 2020 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K930738Surgical Sutures, PGL, Gut, Deklene, Opthamend EtcDeknatel, Inc.19949
0 (this device)K031443Lsi Solutions Suture Quick Load ProductsLsi Solutions2003—
+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—
+1K203120RD QUICK LOAD SUTURE, 0 Polyester, RD QUICK LOAD SUTURE, 2-0 Polyester, RD…Lsi Solutions, Inc.2020—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199910
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201520
201610
202020
202410
FIG. 1 — Lineage of K031443, 1994–2024Source: 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 NEW? 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 NEW device

  1. #1 K252047 STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue…score 15.3 · 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? (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
*K930738Surgical Sutures, PGL, Gut, Deklene, Opthamend Etc
Summary page 2
…5 10(k) Premarket Notification LSI SOLUTIONS@Suture Quick Load@Products Predicate Device: 1. DeknatelTMTevdek@I1 Surgical Suture (K930738) 2. DeknatelTMTevdek@I1 Surgical Suture (K930738) 3. DeknatelTM Tevdek' I1 Surgical Sutur…
Deknatel, Inc.19949
*K984374Surgisorb
Summary page 2
…knatelTM Deklene@I1 Surgical Suture (K930738) 5 . DeknatelTM Deklene@II Surgical Suture (K930738) 6. Surgisorb Absorbable Suture (K984374) 7. Mono-Dox Synthetic Absorbable PDS Suture (K013274) Description: The LSI SOLUTIONS@Suture Quick Lo…
Samyang Corp.1999—
*K013274Mono-Dox, Synthetic Absorbable Polydioxanone Surgical Suture,Sterile
Summary page 2
…atelTM Deklene@II Surgical Suture (K930738) 6. Surgisorb Absorbable Suture (K984374) 7. Mono-Dox Synthetic Absorbable PDS Suture (K013274) Description: The LSI SOLUTIONS@Suture Quick Load@Products, like the predicates, are intended for the…
Cp Medical20013

Also cleared against K930738: 8 other devices →

What descends from it? (7)

2 later devices cite 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
K203120RD QUICK LOAD SUTURE, 0 Polyester, RD QUICK LOAD SUTURE, 2-0 Polyester, RD QUCIK LOAD…Lsi Solutions, Inc.20200

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?

  • 2 of the 3 ancestors have a recall of any class.
  • Of its descendants, K100593 (Lsi Solutions, Inc., 2010) has gone furthest, with 5 descendants of its own.
  • 8 other devices also cite its predicate K930738.

How does its category compare?

All NEW devices

NEW Suture, Surgical, Absorbable, Polydioxanone: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · NEW

6in 2025

2007: 22008: 52010: 32011: 12012: 32013: 52014: 12015: 22016: 32017: 12018: 32019: 42020: 32021: 12022: 12023: 12024: 32025: 62026 (partial year): 5
2007high 6 (2025) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NEW

146in 2025

2008: 22 days median2010: 270 days median2012: 113 days median2013: 32 days median2016: 254 days median2018: 441 days median2019: 144 days median2020: 230 days median2024: 48 days median2025: 146 days median2026 (partial year): 264 days median
2007high 441 (2018) · low 22 (2008)2026

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

Recalls per year · NEW

1in 2022

2008: 12009: 42012: 12013: 12014: 12019: 22022: 1
2007high 4 (2009) · low 0 (2007)2026

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

Adverse event reports per year · NEW

2,504in 2025

2007: 72008: 292009: 422010: 1152011: 592012: 822013: 1852014: 2742015: 2802016: 3212017: 4612018: 9002019: 1,1222020: 1,0102021: 1,4662022: 1,5372023: 1,9752024: 2,1142025: 2,504
2007high 2,504 (2025) · low 7 (2007)2025

MAUDE reports naming product code NEW, 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
20072—07
2008522129
20090—442
201032700115
20111—059
20123113182
20135321185
20141—1274
20152—0280
201632540321
20171—0461
201834410900
2019414421,122
2020323001,010
20211—01,466
20221—11,537
20231—01,975
202434802,114
2025614602,504
202652640—

What is it indicated for?

The SEW-RIGHPQuick Load" Unit with PTFE coated, braided polyester surgical suture is indicated for use in general soft tissue approximation andor ligation. The SEW-RIC;H$ Quick LoadQUnit with monofilament polypropylene surgical suture is indicated for use in general soft tissue approximation andor ligation. The SEW- RIG^ Quick Load@Unit with STRONGSORBTMsynthetic absorbable surgical suture is indicated for use in general soft tissue approximation and/or…

Read the full statement (119 words)

The SEW-RIGHPQuick Load" Unit with PTFE coated, braided polyester surgical suture is indicated for use in general soft tissue approximation andor ligation.

The SEW-RIC;H$ Quick LoadQUnit with monofilament polypropylene surgical suture is indicated for use in general soft tissue approximation andor ligation.

The SEW- RIG^ Quick Load@Unit with STRONGSORBTMsynthetic absorbable surgical suture is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures.

The S E W - R E H ~ Quick Load" Unit with MonoglideTMsynthetic absorbable surgical suture is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures.

Indications for use as stated in the FDA summary.

Also cleared against K930738

8 other devices cite the same predicate.

  • K193530Deklene MAXXTeleflex Medical · 2020
  • K153076silky II POLYDEK, cottony II, TEVDEK II, NextStitch, DEKLENE II, DEKLENE MAXX Gabbay-Frater, NYLON, SILK…Teleflexmedical, Inc. · 2016
  • K120284Digitex Suture Delivery System, Digitexpolypropylene Suture Cartridge Size 0, with Needle and Without…Coloplast A/S · 20121 recall
  • K070673Force Fiber Black CO-Braid Polyethylene Non-Absorbable Surgical SutureTeleflexmedical, Inc. · 2007
  • K021019Cottony II, Silky II Polydek & Tevdek II Polyester SutureGenzyme Corp. · 20027 recalls
  • K993415GDC-10 Stretch Resistant Guglielmi Detachable Coil, GDC-10 2-Diameter Stretch Resistant Guglielmi Detachable…Boston Scientific, Target · 2000

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
  • K040232Lsi Sew-Right R Series Suture Placement Device and Access Product Sew-Right SR-5R, Model 020999Lsi Solutions · 2004
  • 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 NEW

The NEW category page

  • K254238MINT MONO SuturesHans Biomed Corporation · 2026
  • K253879Monofix PdoSamyang Holdings Corporation · 2026
  • K261988Monodek™ (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical SutureTeleflex Medical, LLC · 2026
  • K252171Barbed PDO SutureSutura Medical Technology, Inc. · 2026
  • K252047STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control DevicesETHICON, Inc. · 2026

https://510kreport.com/device/K031443 · printed Nov 6, 2026

Cite this page

510(k) Report. “K031443: Lsi Solutions Suture Quick Load Products.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031443

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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