510(k) · Cleared
ClearedDemequicktm (Rapid Absorbable) Synthetic Surgical Suture
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Demetech Corp. · GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Cleared on May 30, 2014 as substantially equivalent to K120556 (Riverpoint Medical, 2012) and 1 other predicate after a 526-day review. Its family tree reaches back 2 generations to 2002.
- Decided
- May 30, 2014
- Review
- 526 days
- Class
- Class II
- Product code
- GAM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K022269 (2002). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K022269 | Coated Vicryl* (Polyglactin 910) Suture | ETHICON, Inc. | 2002 | 3 |
| −1 | K120556 | Vilet Vilet Quick | Riverpoint Medical | 2012 | 41 |
| 0 (this device) | K123940 | Demequicktm (Rapid Absorbable) Synthetic Surgical Suture | Demetech Corp. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 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 GAM? 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 GAM device
- #1 K252743 STRATAFIX™ Spiral PDS™ Plus Knotless Tissue…score 14.8 · 15 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K120556 | Vilet Vilet QuickSummary page 1…tially equivalent to these following two predicate devices: * Riverpoint's Wlet Quick® Synthetic Absorbable suture, reference 510k number, K120556, Portland, OR. * Ethicon's Vicryl Rapide® Synthetic Absorbable suture, reference 510K number, K033746… | 2012 |
| * | K033746 | Modified Coated Vicryl* Rapide (Polyglactin 910) SutureSummary page 1…e, reference 510k number, K120556, Portland, OR. * Ethicon's Vicryl Rapide® Synthetic Absorbable suture, reference 510K number, K033746, Ethicon Inc. Somerville NJ. F. Device Description: DemeQUICK Absorbable suture is an absorbable sterile surgical sutu… | 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 12 years and passes through 3 companies; a new generation was cleared every 9.7 years on median.
- 3 of the 3 ancestors have a recall of any class.
- 1 other device also cites its predicate K120556.
How does its category compare?
All GAM devicesGAM Suture, Absorbable, Synthetic, Polyglycolic Acid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · GAM
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GAM
29in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GAM
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GAM
8,970in 2025
MAUDE reports naming product code GAM, 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 | 7 | 50 | 10 | 274 |
| 2008 | 6 | 174 | 1 | 194 |
| 2009 | 3 | 10 | 6 | 287 |
| 2010 | 1 | — | 3 | 587 |
| 2011 | 2 | — | 6 | 637 |
| 2012 | 5 | 31 | 0 | 868 |
| 2013 | 1 | — | 0 | 898 |
| 2014 | 10 | 121 | 0 | 1,410 |
| 2015 | 5 | 209 | 0 | 935 |
| 2016 | 3 | 169 | 1 | 1,112 |
| 2017 | 8 | 134 | 1 | 1,499 |
| 2018 | 5 | 98 | 0 | 2,229 |
| 2019 | 4 | 90 | 1 | 3,564 |
| 2020 | 3 | 140 | 44 | 3,415 |
| 2021 | 2 | — | 0 | 4,506 |
| 2022 | 2 | — | 4 | 4,814 |
| 2023 | 1 | — | 0 | 5,070 |
| 2024 | 2 | — | 1 | 7,226 |
| 2025 | 3 | 29 | 0 | 8,970 |
| 2026 | 4 | 131 | 2 | — |
What is it indicated for?
DemeQUICK (Rapid Absorbable) Synthetic Surgical Suture is indicated for use in superficial soft tissue approximation (i.e., mucosa and skin) where only short term wound support (7-10 days) is required. DemeQUICK (Rapid Absorbable) Synthetic Surgical Suture is not intended for use in ligation, cardiovascular, ophthalmic or neurological procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123940 · printed Nov 5, 2026
Cite this page
510(k) Report. “K123940: Demequicktm (Rapid Absorbable) Synthetic Surgical Suture.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K123940
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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