510(k) Report

510(k) · Cleared

Cleared

Tranquill Barbed Device

K133420510(k) SpecialCleared Nov 29, 201321-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

Surgical Specialties Corp. Dba Angiotech · NEW Suture, Surgical, Absorbable, Polydioxanone

Cleared on Nov 29, 2013 as substantially equivalent to K051609 (Quill Medical, Inc., 2005) and 2 other predicates after a 21-day review. Its family tree reaches back 9 generations to 2002. 6 later devices descend from it.

Decided
Nov 29, 2013
Review
21 days
Class
Class II
Product code
NEW
Recalls
None
Predicates
3

Its longest line of descent runs back 9 generations to K014153 (2002). 18 ancestors in all, the oldest K915489 (1992). 6 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2004: 1 other ancestor2003: 1 other ancestor1997: 1 other ancestor2002: 1 other ancestor1998: 2 other ancestors1996: 1 other ancestor1992: 2 other ancestors2019: 2 descendants cleared2018: 1 descendant cleared2024: 2 descendants cleared2025: 1 descendant clearedK014153 · Coapt Systmes Endotine Device · Coapt Systems, Inc. · 2002K023922 · Coapt Systems Endotine Device, Model CFD-101-00197 · Coapt Systems, Inc. · 2002K032698 · Coapt Endotine Midface-ST 4.5 Device · Coapt Systems, Inc. · 2003K041593 · Featherlift Extended Length Aptos Thread · Surgical Specialties Corp · 2004×2: 2 generations cleared close together, K050548 (2005), K051609 (2005) K071989 · Quill Self-Retaining System (SRS) Synthetic Absorbable Surgical Suture Material · Surgical Specialties Corp · 2007×2: 2 generations cleared close together, K080680 (2008), K080985 (2008) 1990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 3 other ancestors3 generations back: 5 other ancestors5 generations back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 3 descendants3 generations forward: 1 descendant K080985 · Quill Self-Retaining System (SRS) Comprised of Polydioxanone (Pdo) · Surgical Specialties Corp · 2008K080680 · Quill Self-Retaining System (SRS) Comprised of Pdo (Polydioxanone · Surgical Specialties Corp · 2008K071989 · Quill Self-Retaining System (SRS) Synthetic Absorbable Surgical Suture Material · Surgical Specialties Corp · 2007K051609 · Quill Synthetic Absorbable Barbed Suture · Quill Medical, Inc. · 2005K050548 · Contour Midface Opposing Uni-Directional Threads · Surgical Specialties Corp · 2005K041593 · Featherlift Extended Length Aptos Thread · Surgical Specialties Corp · 2004K032698 · Coapt Endotine Midface-ST 4.5 Device · Coapt Systems, Inc. · 2003K023922 · Coapt Systems Endotine Device, Model CFD-101-00197 · Coapt Systems, Inc. · 2002K014153 · Coapt Systmes Endotine Device · Coapt Systems, Inc. · 2002−50
  1. Root · 9 generations backK014153 Coapt Systmes Endotine DeviceCoapt Systems, Inc. · 2002
  2. 5 generations between
  3. 3 generations backK071989 Quill Self-Retaining System (SRS) Synthetic Absorbable Surgical…Surgical Specialties Corp · 2007
  4. 2 generations backK080680 Quill Self-Retaining System (SRS) Comprised of Pdo (PolydioxanoneSurgical Specialties Corp · 2008
  5. 1 generation backK080985 Quill Self-Retaining System (SRS) Comprised of Polydioxanone (Pdo)Surgical Specialties Corp · 2008
  6. This deviceK133420 Tranquill Barbed DeviceSurgical Specialties Corp. Dba Angiotech · 2013
  7. Descendant · cites it directly · 4 of its ownK172602 MiracuFeeltech Co., Ltd. · 2018
  8. Descendant · 2 generations on · 1 of its ownK240389 Secret Line up (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150 )…Hyundae Meditech Co., Ltd. · 2024
  9. Descendant · 2 generations on · 0 of its ownK250107 V-soft Line™ Barbed Surgical Suture (Various)Feeltech Co., Ltd. · 2025
  10. Descendant · 3 generations on · 0 of its ownK242571 Secret Line up (FC1938E80 FC1950E90 FC1960E100 FC1970E120 FC1990E150…Hyundae Meditech Co., Ltd. · 2024
  11. Descendant · cites it directly · 0 of its ownK190264 ViolaMeditime Co., Ltd. · 2019
Show all 9 generations
  1. Root · 9 generations backK014153 Coapt Systmes Endotine DeviceCoapt Systems, Inc. · 2002
  2. 8 generations backK023922 Coapt Systems Endotine Device, Model CFD-101-00197Coapt Systems, Inc. · 2002
  3. 7 generations backK032698 Coapt Endotine Midface-ST 4.5 DeviceCoapt Systems, Inc. · 2003
  4. 6 generations backK041593 Featherlift Extended Length Aptos ThreadSurgical Specialties Corp · 2004
  5. 5 generations backK050548 Contour Midface Opposing Uni-Directional ThreadsSurgical Specialties Corp · 2005
  6. 4 generations backK051609 Quill Synthetic Absorbable Barbed SutureQuill Medical, Inc. · 2005
  7. 3 generations backK071989 Quill Self-Retaining System (SRS) Synthetic Absorbable Surgical…Surgical Specialties Corp · 2007
  8. 2 generations backK080680 Quill Self-Retaining System (SRS) Comprised of Pdo (PolydioxanoneSurgical Specialties Corp · 2008
  9. 1 generation backK080985 Quill Self-Retaining System (SRS) Comprised of Polydioxanone (Pdo)Surgical Specialties Corp · 2008
  10. This deviceK133420 Tranquill Barbed DeviceSurgical Specialties Corp. Dba Angiotech · 2013

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2018: 12019: 22024: 22025: 1
2018high 2 (2019) · low 0 (2020)2026

Most influential descendants

Showing 5 of 6 · See all
  • K172602MiracuFeeltech Co., Ltd. · 2018 · cites it directly4descendants
  • K240389Secret Line up (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150 ); i-Thread…Hyundae Meditech Co., Ltd. · 2024 · 2 generations on1descendant
  • K250107V-soft Line™ Barbed Surgical Suture (Various)Feeltech Co., Ltd. · 2025 · 2 generations on0descendants
  • K242571Secret Line up (FC1938E80 FC1950E90 FC1960E100 FC1970E120 FC1990E150 FC19100E150…Hyundae Meditech Co., Ltd. · 2024 · 3 generations on0descendants
  • K190264ViolaMeditime Co., Ltd. · 2019 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−9K014153Coapt Systmes Endotine DeviceCoapt Systems, Inc.2002—
−8K023922Coapt Systems Endotine Device, Model CFD-101-00197Coapt Systems, Inc.2002—
−7K032698Coapt Endotine Midface-ST 4.5 DeviceCoapt Systems, Inc.2003—
−6K041593Featherlift Extended Length Aptos ThreadSurgical Specialties Corp2004—
−5K050548Contour Midface Opposing Uni-Directional ThreadsSurgical Specialties Corp2005—
−4K051609Quill Synthetic Absorbable Barbed SutureQuill Medical, Inc.2005—
−3K071989Quill Self-Retaining System (SRS) Synthetic Absorbable Surgical Suture MaterialSurgical Specialties Corp2007—
−2K080680Quill Self-Retaining System (SRS) Comprised of Pdo (PolydioxanoneSurgical Specialties Corp2008—
−1K080985Quill Self-Retaining System (SRS) Comprised of Polydioxanone (Pdo)Surgical Specialties Corp2008—
0 (this device)K133420Tranquill Barbed DeviceSurgical Specialties Corp. Dba Angiotech2013—
+1K172602MiracuFeeltech Co., Ltd.2018—
+2K240389Secret Line up (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150 ); i-Thread…Hyundae Meditech Co., Ltd.2024—
+2K250107V-soft Line™ Barbed Surgical Suture (Various)Feeltech Co., Ltd.2025—
+3K242571Secret Line up (FC1938E80 FC1950E90 FC1960E100 FC1970E120 FC1990E150…Hyundae Meditech Co., Ltd.2024—
+1K190264ViolaMeditime Co., Ltd.2019—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199220
199610
199710
199820
200210
200310
200410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201810
201920
202420
202510
FIG. 1 — Lineage of K133420, 2002–2025Source: 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
*K051609Quill Synthetic Absorbable Barbed Suture
Summary page 1
…rbed device, comprised of Polydioxanone Polydioxanone Absorbable Surgical Suture Absorbable polydioxanone surgical suture Product code, NEW 21 CFR 878.4840 Class I1 K051609: Quill Synthetic Absorbable Barbed Suture K080680 Quill™ Self-Retaining System (SRS) . comprised of PDO K080985 Quill™ Self…
Quill Medical, Inc.2005—
*K080680Quill Self-Retaining System (SRS) Comprised of Pdo (Polydioxanone
Summary page 1
…ne Absorbable Surgical Suture Absorbable polydioxanone surgical suture Product code, NEW 21 CFR 878.4840 Class I1 K051609: Quill Synthetic Absorbable Barbed Suture K080680 Quill™ Self-Retaining System (SRS) . comprised of PDO K080985 Quill™ Self-Retaining System (SRS) comprised of PDO The Tr…
Surgical Specialties Corp2008—
*K080985Quill Self-Retaining System (SRS) Comprised of Polydioxanone (Pdo)
Summary page 1
…uture Product code, NEW 21 CFR 878.4840 Class I1 K051609: Quill Synthetic Absorbable Barbed Suture K080680 Quill™ Self-Retaining System (SRS) . comprised of PDO K080985 Quill™ Self-Retaining System (SRS) comprised of PDO The TranQuill barbed device is a sterile. synthetic absorbable device th…
Surgical Specialties Corp2008—

Also cleared against K051609: 10 other devices →

What descends from it? (6)

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

NumberDeviceApplicantDecidedDescendants
K172602MiracuFeeltech Co., Ltd.20184
K190264ViolaMeditime Co., Ltd.20190

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 11 years and passes through 4 companies; a new generation was cleared every 9 months on median.
  • 4 of the 18 ancestors have a recall of any class.
  • Of its descendants, K172602 (Feeltech Co., Ltd., 2018) has gone furthest, with 4 descendants of its own.
  • 10 other devices also cite its predicate K051609.

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. 2013, this device’s year, is highlighted.

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 TranQuill barbed device comprised of polydioxanone, is indicated for soft tissue approximation where use of an absorbable suture is appropriate.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K051609

10 other devices cite the same predicate.

  • K173874StitchKit V-Loc 90, StitchKit V-Loc 180, StitchKit Quill PDOOrigami Surgical, LLC · 2018
  • K120827Quill Pdo Knotless Tissue-Closure Device (Polydixanone)Angiotech · 2012
  • K113744Quill Pdo Knotless Tissue-Closure Device (Polydioxanone)Angiotech · 2012
  • K080985Quill Self-Retaining System (SRS) Comprised of Polydioxanone (Pdo)Surgical Specialties Corp · 2008
  • K080680Quill Self-Retaining System (SRS) Comprised of Pdo (PolydioxanoneSurgical Specialties Corp · 2008
  • K071989Quill Self-Retaining System (SRS) Synthetic Absorbable Surgical Suture MaterialSurgical Specialties Corp · 2007

More from Surgical Specialties Corp. Dba Angiotech

7 FDA decisions under this applicant name. See the company

  • K131224Sharpoint Polypropylene Surgical Suture, Look Polypropylene Surgical Suture, Quill Polypropylene Knotless…Surgical Specialties Corp. Dba Angiotech · 2013
  • K130078Quill Polypropylene Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corp. Dba Angiotech · 2013
  • K123877Quill Pdo Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corp. Dba Angiotech · 2013
  • K123836Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corp. Dba Angiotech · 2012
  • K123409Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corp. Dba Angiotech · 2012

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/K133420 · printed Nov 6, 2026

Cite this page

510(k) Report. “K133420: Tranquill Barbed Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133420

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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