510(k) · Cleared
ClearedOne-Stop
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mediclus Co., Ltd. · MVL Cord, Retraction
Cleared on Feb 27, 2026 as substantially equivalent to K162662 (Pac-Dent International, Inc., 2017) after a 91-day review. Its family tree reaches back 2 generations to 2005.
- Decided
- Feb 27, 2026
- Review
- 91 days
- Class
- Class U
- Product code
- MVL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K050180 (2005). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 |
|---|---|---|---|
| * | K162662 | GingiDent Gingival Retraction PasteSummary page 5…lassified • Product Code: MVL • Classification regulation: 21 CFR 4. Predicate Device: GingiDent Gingival Retraction Paste by Pac-Dent International, Inc (K162662) 5. Description: One-Stop is a paste-type topical pre-impression agent intended to provide gingival retraction and hemo… | 2017 |
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 21 years and passes through 3 companies; a new generation was cleared every 12.7 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All MVL devicesMVL Cord, Retraction: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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?
One-Stop is intended for the temporary retraction and hemostasis of the gingival margin during dental procedures such as, but not limited to, taking an impression, cementation, and cavity preparation.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K253797 · printed Nov 4, 2026
Cite this page
510(k) Report. “K253797: One-Stop.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K253797
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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