510(k) Report

510(k) · Cleared

Cleared

Lariat II Suture Delivery Device

K090385510(k) TraditionalCleared May 6, 200978-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

Sentreheart, Inc. · GAT Suture, Nonabsorbable, Synthetic, Polyethylene

Cleared on May 6, 2009 as substantially equivalent to K060721 (Sentreheart, 2006) and 3 other predicates after a 78-day review. Its family tree reaches back 3 generations to 1994. 2 later devices descend from it.

Decided
May 6, 2009
Review
78 days
Class
Class II
Product code
GAT
Recalls
None
Predicates
4

Its longest line of descent runs back 3 generations to K931994 (1994). 8 ancestors in all, the oldest K905379 (1991). 2 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2002: 1 other ancestor1996: 1 other ancestor1991: 1 other ancestor2000: 1 other ancestor1995: 1 other ancestor2014: 1 descendant cleared2015: 1 descendant clearedReference device: K021019 · Cottony II, Silky II Polydek & Tevdek II Polyester Suture · Genzyme Corp. · 2002 · recalledK931994 · Resectoscope Sheath · Olympus Corp. · 1994K993695 · Liga-Loop Suture Applicator · Hysterx, Inc. · 2000K060721 · Lariat Loop Applicator · Sentreheart · 20061990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 1 other ancestor3 generations back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 1 descendant K060721 · Lariat Loop Applicator · Sentreheart · 2006K993695 · Liga-Loop Suture Applicator · Hysterx, Inc. · 2000K931994 · Resectoscope Sheath · Olympus Corp. · 19940
  1. Root · 3 generations backK931994 Resectoscope SheathOlympus Corp. · 1994
  2. 2 generations backK993695 Liga-Loop Suture ApplicatorHysterx, Inc. · 2000
  3. 1 generation backK060721 Lariat Loop ApplicatorSentreheart · 2006
  4. This deviceK090385 Lariat II Suture Delivery DeviceSentreheart, Inc. · 2009
  5. Descendant · cites it directly · 1 of its ownK142241 LARIAT sulture Delivery DeviceSentreheart, Inc. · 2014
  6. Descendant · 2 generations on · 0 of its ownK153096 LARIAT RS Suture Delivery DeviceSentreheart, Inc. · 2015

Most influential descendants

Showing 2 of 2 · See all
  • K142241LARIAT sulture Delivery DeviceSentreheart, Inc. · 2014 · cites it directly1descendant
  • K153096LARIAT RS Suture Delivery DeviceSentreheart, Inc. · 2015 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K931994Resectoscope SheathOlympus Corp.1994—
−2K993695Liga-Loop Suture ApplicatorHysterx, Inc.2000—
−1K060721Lariat Loop ApplicatorSentreheart2006—
0 (this device)K090385Lariat II Suture Delivery DeviceSentreheart, Inc.2009—
+1K142241LARIAT sulture Delivery DeviceSentreheart, Inc.2014—
+2K153096LARIAT RS Suture Delivery DeviceSentreheart, Inc.2015—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199110
199510
199610
200010
200210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
201510
FIG. 1 — Lineage of K090385, 1994–2015Source: 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? (4)

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
*K060721Lariat Loop Applicator
Summary page 2
…510(k) Notification SECTION 4 - 510(k) SUMMARY Predicate Devices: Lariat Loop Applicator, SentreHEART (K060721) Endosuture System, Ethicon Endo-Surgery (K963329) Saph-Loop Ligating Loop, Genzyme (K022410) Surgietie Ligating Loop US Surgical…
Sentreheart2006—
*K963329Ethicon Endosuture System
Summary page 2
…SECTION 4 - 510(k) SUMMARY Predicate Devices: Lariat Loop Applicator, SentreHEART (K060721) Endosuture System, Ethicon Endo-Surgery (K963329) Saph-Loop Ligating Loop, Genzyme (K022410) Surgietie Ligating Loop US Surgical (K905379) Safety and Performance: Performance Fu…
ETHICON, Inc.1996—
*K022410Saph-Loop Ligating Loop
Summary page 2
…N 4 - 510(k) SUMMARY Predicate Devices: Lariat Loop Applicator, SentreHEART (K060721) Endosuture System, Ethicon Endo-Surgery (K963329) Saph-Loop Ligating Loop, Genzyme (K022410) Surgietie Ligating Loop US Surgical (K905379) Safety and Performance: Performance Functional testing was conducted to support t…
Genzyme Biosurgery2002—
*K905379Auto Suture Modified Surgitie Endo. Ligating Loop
Summary page 2
…Loop Applicator, SentreHEART (K060721) Endosuture System, Ethicon Endo-Surgery (K963329) Saph-Loop Ligating Loop, Genzyme (K022410) Surgietie Ligating Loop US Surgical (K905379) Safety and Performance: Performance Functional testing was conducted to support the claim of substantial equivalence and to dem…
United States Surgical, A Division of Tyco Healthc1991—
†K021019Cottony II, Silky II Polydek & Tevdek II Polyester SutureGenzyme Corp.20027

Also cleared against K060721: 1 other device →

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K142241LARIAT sulture Delivery DeviceSentreheart, Inc.20141

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 15 years and passes through 4 companies; a new generation was cleared every 6.1 years on median.
  • 1 of the 8 ancestors has a recall of any class.
  • Of its descendants, K142241 (Sentreheart, Inc., 2014) has gone furthest, with 1 descendant of its own.
  • 1 other device also cites its predicate K060721.

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. 2009, this device’s year, is highlighted.

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?

The LARIAT II Suture Delivery Device facilitates suture placement and knot tying for use in surgical applications where soft tissue are being approximated and/or ligated with a pre-tied polyester suture.

Indications for use as stated in the FDA summary.

Also cleared against K060721

1 other device cites the same predicate.

  • K073096Anchorage Closure DeviceEpitek, Inc. · 2008

More from Sentreheart, Inc.

5 FDA decisions under this applicant name. See the company

  • K153096LARIAT RS Suture Delivery DeviceSentreheart, Inc. · 2015
  • K142241LARIAT sulture Delivery DeviceSentreheart, Inc. · 2014
  • K080364Findrwirz Guide Wire SystemSentreheart, Inc. · 20081 Class I recall
  • K070126Occlusion Balloon CatheterSentreheart, Inc. · 2008

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/K090385 · printed Nov 6, 2026

Cite this page

510(k) Report. “K090385: Lariat II Suture Delivery Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090385

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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