510(k) · Cleared
ClearedRD QUICK LOAD SUTURE, 0 Polyester, RD QUICK LOAD SUTURE, 2-0 Polyester, RD QUCIK LOAD SUTURE, 2-0 Polypropylene
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lsi Solutions, Inc. · GAS Suture, Nonabsorbable, Synthetic, Polyester
Cleared on Nov 24, 2020 as substantially equivalent to K031443 (Lsi Solutions, 2003) after a 39-day review. Its family tree reaches back 2 generations to 1994.
- Decided
- Nov 24, 2020
- Review
- 39 days
- Class
- Class II
- Product code
- GAS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K930738 (1994). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK930738 Surgical Sutures, PGL, Gut, Deklene, Opthamend EtcDeknatel, Inc. · 1994 · Recalled
- 1 generation backK031443 Lsi Solutions Suture Quick Load ProductsLsi Solutions · 2003
- This deviceK203120 RD QUICK LOAD SUTURE, 0 Polyester, RD QUICK LOAD SUTURE, 2-0…Lsi Solutions, Inc. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K930738 | Surgical Sutures, PGL, Gut, Deklene, Opthamend Etc | Deknatel, Inc. | 1994 | 9 |
| −1 | K031443 | Lsi Solutions Suture Quick Load Products | Lsi Solutions | 2003 | — |
| 0 (this device) | K203120 | RD QUICK LOAD SUTURE, 0 Polyester, RD QUICK LOAD SUTURE, 2-0 Polyester, RD… | Lsi Solutions, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2001 | 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 K203081 RAM COR-SUTURE QUCIK LOAD Surgical Suture…score 1.9 · 6 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 |
|---|---|---|---|
| * | K031443 | Lsi Solutions Suture Quick Load ProductsSummary page 5…LOAD® with 0 Polyester, SEW- RIGHT® QUICK LOAD® with 2-0 Polyester and SEW-RIGHT® QUICK LOAD® with 2-0 Polypropylene, which was cleared in 510(k) Premarket Notification K031443 on June 18, 2003. The predicate device will herein be referred to as SEW-RIGHT® QUICK LOAD® suture. This predicate has not been s… | 2003 |
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 26 years and passes through 3 companies; a new generation was cleared every 17.4 years on median.
- 2 of the 4 ancestors have a recall of any class.
- 1 other device also cites its predicate K031443.
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 RD® QUICK LOAD® suture is intended for use in general soft tissue approximation and/or ligation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K203120 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203120: RD QUICK LOAD SUTURE, 0 Polyester, RD QUICK LOAD SUTURE, 2-0 Polyester, RD QUCIK LOAD SUTURE, 2-0 Polypropylene.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203120
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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