510(k) · Cleared
ClearedDekna-Lok Model BP1000V2L
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Teleflex Medical · GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Cleared on May 17, 2006 as substantially equivalent to K992088 (Genzyme Surgical Product (Genzyme Biosurgery), 1999) after a 54-day review. Its family tree reaches back 3 generations to 1990.
- Decided
- May 17, 2006
- Review
- 54 days
- Class
- Class II
- Product code
- GAM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K900198 (1990). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK900198 Dexon II Absorbable Surgical Suture, U.S.P.American Cyanamid Co. · 1990
- 2 generations backK972566 Dexon VioletDavis & Geck, Inc. · 1997
- 1 generation backK992088 Bondek Plus Polyglycolic Acid Synthetic Absorbable Surgical SutureGenzyme Surgical Product (Genzyme Biosurgery) · 1999 · Recalled
- This deviceK060801 Dekna-Lok Model BP1000V2LTeleflex Medical · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K900198 | Dexon II Absorbable Surgical Suture, U.S.P. | American Cyanamid Co. | 1990 | — |
| −2 | K972566 | Dexon Violet | Davis & Geck, Inc. | 1997 | — |
| −1 | K992088 | Bondek Plus Polyglycolic Acid Synthetic Absorbable Surgical Suture | Genzyme Surgical Product (Genzyme Biosurgery) | 1999 | 6 |
| 0 (this device) | K060801 | Dekna-Lok Model BP1000V2L | Teleflex Medical | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1995 | 2 | 0 |
| 1997 | 1 | 0 |
| 1999 | 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? (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 |
|---|---|---|---|
| * | K992088 | Bondek Plus Polyglycolic Acid Synthetic Absorbable Surgical SutureSummary page 2…dures. G. Substantial Equivalence Dekna-lokTM is substantially equivalent to Teleflex Medical's Bondek® Plus Polyglycolic Acid Synthetic Absorbable Suture (K992088) with respect to functionality, design, and intended use and performance characteristics. H. Summary of Testing All… | 1999 |
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 16 years and passes through 4 companies; a new generation was cleared every 6.7 years on median.
- 5 of the 9 ancestors have a recall of any class.
- 3 other devices also cite its predicate K992088.
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.
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?
Dekna-lokTM is indicated for use in general soft tissue approximation and/or ligation, but not for cardiovascular, neurological or ophthalmic procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060801 · printed Nov 5, 2026
Cite this page
510(k) Report. “K060801: Dekna-Lok Model BP1000V2L.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K060801
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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