510(k) · Cleared
ClearedUnicaprone
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
United Medical Industries Co., Ltd. · GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Cleared on Nov 7, 2007 after a 50-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 3 later devices descend from it.
- Decided
- Nov 7, 2007
- Review
- 50 days
- Class
- Class II
- Product code
- GAM
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK072646 UnicaproneUnited Medical Industries Co., Ltd. · 2007
- Descendant · cites it directly · 2 of its ownK081002 Monoglyde, Absorbable (Poliglecaprone 25) SutureSutures India Pvt., Ltd. · 2008
- Descendant · 2 generations on · 1 of its ownK130083 Demecaprone (Poliglecaprone 25) Synthetic Monofilament (PGCL)…Demetech Corp. · 2013
- Descendant · 3 generations on · 0 of its ownK232372 Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME)Peters Surgical · 2024
Most influential descendants
Showing 3 of 3 · See all- K081002Monoglyde, Absorbable (Poliglecaprone 25) SutureSutures India Pvt., Ltd. · 2008 · cites it directly2descendants
- K130083Demecaprone (Poliglecaprone 25) Synthetic Monofilament (PGCL) Absorbable SutureDemetech Corp. · 2013 · 2 generations on1descendant
- K232372Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME)Peters Surgical · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K072646 | Unicaprone | United Medical Industries Co., Ltd. | 2007 | — |
| +1 | K081002 | Monoglyde, Absorbable (Poliglecaprone 25) Suture | Sutures India Pvt., Ltd. | 2008 | — |
| +2 | K130083 | Demecaprone (Poliglecaprone 25) Synthetic Monofilament (PGCL) Absorbable Suture | Demetech Corp. | 2013 | — |
| +3 | K232372 | Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME) | Peters Surgical | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2013 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081002 | Monoglyde, Absorbable (Poliglecaprone 25) Suture | 2008 | 2 |
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?
- Of its descendants, K081002 (Sutures India Pvt., Ltd., 2008) has gone furthest, with 2 descendants of its own.
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. 2007, 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 | — |
https://510kreport.com/device/K072646 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072646: Unicaprone.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072646
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026