510(k) · Cleared
ClearedRAM COR-SUTURE QUCIK LOAD Surgical Suture, COR-SUTURE QUICK LOAD Surgical Suture
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lsi Solutions · GAS Suture, Nonabsorbable, Synthetic, Polyester
Cleared on Nov 24, 2020 as substantially equivalent to K160529 (Lsi Soultions, 2016) after a 42-day review. Its family tree reaches back 6 generations to 1993.
- Decided
- Nov 24, 2020
- Review
- 42 days
- Class
- Class II
- Product code
- GAS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K933887 (1993). 16 ancestors in all, the oldest K771412 (1977). No later device cites it as a predicate yet.
- Root · 6 generations backK933887 Implantable ClipUnited States Surgical, A Division of Tyco Healthc · 1993
- 5 generations backK962043 Auto Suture Modified VCS Clip ApplierUnited States Surgical, A Division of Tyco Healthc · 1996 · Recalled
- 4 generations backK994160 Coalescent Surgical Sutured-ClipCoalescent Surgical · 2000
- 3 generations backK012317 Coalescent Surgical U-ClipCoalescent Surgical · 2001
- 2 generations backK100593 Suture Placement Device and Accessories, Flexible Suture Placement…Lsi Solutions, Inc. · 2010
- 1 generation backK160529 Pledgeted COR-SUTURE QUICK LOADLsi Soultions · 2016
- This deviceK203081 RAM COR-SUTURE QUCIK LOAD Surgical Suture, COR-SUTURE QUICK LOAD…Lsi Solutions · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K933887 | Implantable Clip | United States Surgical, A Division of Tyco Healthc | 1993 | — |
| −5 | K962043 | Auto Suture Modified VCS Clip Applier | United States Surgical, A Division of Tyco Healthc | 1996 | 7 |
| −4 | K994160 | Coalescent Surgical Sutured-Clip | Coalescent Surgical | 2000 | — |
| −3 | K012317 | Coalescent Surgical U-Clip | Coalescent Surgical | 2001 | — |
| −2 | K100593 | Suture Placement Device and Accessories, Flexible Suture Placement Device and… | Lsi Solutions, Inc. | 2010 | — |
| −1 | K160529 | Pledgeted COR-SUTURE QUICK LOAD | Lsi Soultions | 2016 | — |
| 0 (this device) | K203081 | RAM COR-SUTURE QUCIK LOAD Surgical Suture, COR-SUTURE QUICK LOAD Surgical Suture | Lsi Solutions | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1977 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 2 | 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 GAS? 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 GAS device
- #1 K203120 RD QUICK LOAD SUTURE, 0 Polyester, RD QUICK…score 0.7 · 2 generations · no Class I recall
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K160529 | Pledgeted COR-SUTURE QUICK LOADSummary page 5…™ Pledgeted COR-SUTURE September 15, LSI SOLUTIONS, Inc. K160529 QUICK LOAD® 2016 Device Description LSI SOLUTIONS®… | 2016 |
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 27 years and passes through 5 companies; a new generation was cleared every 4.2 years on median.
- 4 of the 16 ancestors have a recall of any class.
How does its category compare?
All GAS devicesGAS Suture, Nonabsorbable, Synthetic, Polyester: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · GAS
2in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · GAS
Too few GAS 510(k)s in any year since 2007 to give a median.
Recalls per year · GAS
No recall names GAS since 2007.
Adverse event reports per year · GAS
3in 2025
MAUDE reports naming product code GAS, 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 | 35 |
| 2008 | 0 | — | 0 | 47 |
| 2009 | 0 | — | 0 | 56 |
| 2010 | 1 | — | 0 | 24 |
| 2011 | 0 | — | 0 | 25 |
| 2012 | 0 | — | 0 | 73 |
| 2013 | 0 | — | 0 | 21 |
| 2014 | 0 | — | 0 | 12 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 3 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The RAM® COR-SUTURE® QUICK LOAD® surgical suture is indicated for use in the approximation of soft tissue and prosthetic materials.
The COR-SUTURE® QUICK LOAD® surgical suture is indicated for use in the approximation of soft tissue and prosthetic materials.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K203081 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203081: RAM COR-SUTURE QUCIK LOAD Surgical Suture, COR-SUTURE QUICK LOAD Surgical Suture.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203081
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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