510(k) · Cleared
ClearedQuill Nonabsorbable Nylon Barbed Suture
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quill Medical, Inc. · GAR Suture, Nonabsorbable, Synthetic, Polyamide
Cleared on Nov 28, 2005 as substantially equivalent to K930825 (Surgical Specialties, Inc., 1994) and 2 other predicates after a 45-day review. Its family tree reaches back 7 generations to 2002.
- Decided
- Nov 28, 2005
- Review
- 45 days
- Class
- Class II
- Product code
- GAR
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K014153 (2002). 18 ancestors in all, the oldest K915489 (1992). No later device cites it as a predicate yet.
- Root · 7 generations backK014153 Coapt Systmes Endotine DeviceCoapt Systems, Inc. · 2002
- 6 generations backK023922 Coapt Systems Endotine Device, Model CFD-101-00197Coapt Systems, Inc. · 2002
- 5 generations backK032698 Coapt Endotine Midface-ST 4.5 DeviceCoapt Systems, Inc. · 2003
- 4 generations backK041593 Featherlift Extended Length Aptos ThreadSurgical Specialties Corp · 2004
- 3 generations backK050548 Contour Midface Opposing Uni-Directional ThreadsSurgical Specialties Corp · 2005
- 2 generations backK051609 Quill Synthetic Absorbable Barbed SutureQuill Medical, Inc. · 2005
- 1 generation backK052373 Quill Nonabsorbable Polypropylene Barbed SutureQuill Medical, Inc. · 2005
- This deviceK052900 Quill Nonabsorbable Nylon Barbed SutureQuill Medical, Inc. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K014153 | Coapt Systmes Endotine Device | Coapt Systems, Inc. | 2002 | — |
| −6 | K023922 | Coapt Systems Endotine Device, Model CFD-101-00197 | Coapt Systems, Inc. | 2002 | — |
| −5 | K032698 | Coapt Endotine Midface-ST 4.5 Device | Coapt Systems, Inc. | 2003 | — |
| −4 | K041593 | Featherlift Extended Length Aptos Thread | Surgical Specialties Corp | 2004 | — |
| −3 | K050548 | Contour Midface Opposing Uni-Directional Threads | Surgical Specialties Corp | 2005 | — |
| −2 | K051609 | Quill Synthetic Absorbable Barbed Suture | Quill Medical, Inc. | 2005 | — |
| −1 | K052373 | Quill Nonabsorbable Polypropylene Barbed Suture | Quill Medical, Inc. | 2005 | — |
| 0 (this device) | K052900 | Quill Nonabsorbable Nylon Barbed Suture | Quill Medical, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 2 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
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 GAR? 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 GAR device
- #1 K261484 Tissue Approximation Systemscore 11.7 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K930825 | Suture Nonabsorbable-Nylon,Silk,Polyester,StainlesSummary page 1…following predicate devices: a. Predicate for Material: N Nonabsorbable Nylon Surgical Sutures by Surgical Specialties Corp., 5 10(k) K930825 • Grams Nylon Nonabsorbable Suture by GramisMcd, LLC, 510(k) K003000 b. Predicate for Indicati… | 1994 |
| * | K003000 | Grams Nylon Nonabsorbable SutureSummary page 1…lon Surgical Sutures by Surgical Specialties Corp., 5 10(k) K930825 • Grams Nylon Nonabsorbable Suture by GramisMcd, LLC, 510(k) K003000 b. Predicate for Indication for Use based on Technoloizical Characteristics: oQuill® Nonabsorbable Polyprop… | 2000 |
| * | K052373 | Quill Nonabsorbable Polypropylene Barbed SutureSummary page 3…Su tures, Barbed Sutures, 5 10O(k) TBD Sutures, Sutues, 510(k) 510(k) K052373 T BD__________510(k) K930825 510(k)_____… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
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 3 years and passes through 3 companies; a new generation was cleared every 6 months on median.
- 5 of the 18 ancestors have a recall of any class.
- 1 other device also cites its predicate K930825.
How does its category compare?
All GAR devicesGAR Suture, Nonabsorbable, Synthetic, Polyamide: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GAR
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · GAR
Too few GAR 510(k)s in any year since 2007 to give a median.
Recalls per year · GAR
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GAR
823in 2025
MAUDE reports naming product code GAR, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 18 |
| 2008 | 1 | — | 1 | 14 |
| 2009 | 0 | — | 0 | 12 |
| 2010 | 0 | — | 0 | 39 |
| 2011 | 0 | — | 1 | 8 |
| 2012 | 0 | — | 0 | 5 |
| 2013 | 1 | — | 0 | 42 |
| 2014 | 0 | — | 0 | 103 |
| 2015 | 1 | — | 0 | 86 |
| 2016 | 1 | — | 0 | 124 |
| 2017 | 1 | — | 0 | 180 |
| 2018 | 0 | — | 0 | 541 |
| 2019 | 0 | — | 0 | 518 |
| 2020 | 1 | — | 0 | 384 |
| 2021 | 1 | — | 0 | 532 |
| 2022 | 1 | — | 0 | 549 |
| 2023 | 1 | — | 1 | 607 |
| 2024 | 0 | — | 0 | 668 |
| 2025 | 0 | — | 0 | 823 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
Quill® Nonabsorbable Nylon Barbed Sutures are indicated for soft tissue approximation excluding closure of the epidermis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052900 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052900: Quill Nonabsorbable Nylon Barbed Suture.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052900
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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