510(k) · Cleared
ClearedHemostasyl Paste
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Satelec · MVL Cord, Retraction
Cleared on Dec 17, 2008 as substantially equivalent to K050180 (Produits Dentaires Pierre Rolland, 2005) after a 142-day review. Its family tree reaches back 1 generation to 2005. 2 later devices descend from it.
- Decided
- Dec 17, 2008
- Review
- 142 days
- Class
- Class U
- Product code
- MVL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K050180 (2005). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK050180 Expa-SylProduits Dentaires Pierre Rolland · 2005
- This deviceK082116 Hemostasyl PasteSatelec · 2008
- Descendant · cites it directly · 0 of its ownK111978 Sulcus BlueProduits Dentaires Pierre Rolland · 2011
- Descendant · cites it directly · 0 of its ownK093721 COSP23M Espe AG Dental Products · 2010
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K050180 | Expa-Syl | Produits Dentaires Pierre Rolland | 2005 | — |
| 0 (this device) | K082116 | Hemostasyl Paste | Satelec | 2008 | — |
| +1 | K111978 | Sulcus Blue | Produits Dentaires Pierre Rolland | 2011 | — |
| +1 | K093721 | COSP2 | 3M Espe AG Dental Products | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 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 MVL? 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 MVL device
- #1 K254239 CyClean Cordscore 11.4 · 2 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 |
|---|---|---|---|
| * | K050180 | Expa-SylSummary page 1…ORD Classification Name: Unclassified 3. Devices for which Substantial Ecuivalence is claimed: EXPASYL (PRODUITS DENTAIRES PIERRE ROLLAND) K050180 Dated: 11/02/2005 9 510(k… | 2005 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All MVL devicesMVL Cord, Retraction: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · MVL
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MVL
227in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MVL
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MVL
1in 2025
MAUDE reports naming product code MVL, 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 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 3 | 91 | 0 | 1 |
| 2010 | 4 | 79 | 0 | 1 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 7 |
| 2013 | 2 | — | 0 | 5 |
| 2014 | 2 | — | 0 | 2 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 4 | 227 | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 3 |
| 2022 | 2 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 1 | — | 0 | 1 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
Hemostasyl Paste achieves its hemostatic effect in the gingival sulcus by physical and mechanical means during dental procedures such as dental impressions, scaling, seating of temporary and permanent restorations, and placement of a rubber dam.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082116 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082116: Hemostasyl Paste.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082116
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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