510(k) · Cleared
ClearedKnit-Pak+
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Premier Dental Products Co. · MVL Cord, Retraction
Cleared on Nov 26, 2013 after a 106-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 4 later devices descend from it.
- Decided
- Nov 26, 2013
- Review
- 106 days
- Class
- Class U
- Product code
- MVL
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK132526 Knit-Pak+Premier Dental Products Co. · 2013
- Descendant · cites it directly · 1 of its ownK171577 Smartcord, Smartcord XEastdent Co., Ltd. · 2018
- Descendant · cites it directly · 1 of its ownK162536 GingiKnit+, GingiBraid+, GingiBraid+ Shortcut, and UniBraid+…Kerr Corporation · 2017
- Descendant · 2 generations on · 0 of its ownK254239 CyClean CordSS Global · 2026
- Descendant · 2 generations on · 0 of its ownK162948 Styptin, Hemogin-L, Hemodettes, and GingiGEL Aluminum Chloride…Kerr Corporation · 2017
Most influential descendants
Showing 4 of 4 · See all- K171577Smartcord, Smartcord XEastdent Co., Ltd. · 2018 · cites it directly1descendant
- K162536GingiKnit+, GingiBraid+, GingiBraid+ Shortcut, and UniBraid+ impregnated Aluminum…Kerr Corporation · 2017 · cites it directly1descendant
- K254239CyClean CordSS Global · 2026 · 2 generations on0descendants
- K162948Styptin, Hemogin-L, Hemodettes, and GingiGEL Aluminum Chloride Impregnated Retraction…Kerr Corporation · 2017 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K132526 | Knit-Pak+ | Premier Dental Products Co. | 2013 | — |
| +1 | K171577 | Smartcord, Smartcord X | Eastdent Co., Ltd. | 2018 | — |
| +1 | K162536 | GingiKnit+, GingiBraid+, GingiBraid+ Shortcut, and UniBraid+ impregnated… | Kerr Corporation | 2017 | — |
| +2 | K254239 | CyClean Cord | SS Global | 2026 | — |
| +2 | K162948 | Styptin, Hemogin-L, Hemodettes, and GingiGEL Aluminum Chloride Impregnated… | Kerr Corporation | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (4)
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?
- Of its descendants, K171577 (Eastdent Co., Ltd., 2018) has gone furthest, with 1 descendant of its own.
How does its category compare?
All MVL devicesMVL Cord, Retraction: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
Knil-Pak+, a prescription-only, Aluminum Chloride Hexahydratc impregnated cord is used for temporary chemo-mechanical retraction of gingival tissues and hemostasis of the gingival margin around the tooth. It is intended for accurate and enhanced results when acquiring dental impressions, for cavity preparation or wherever heniostasis and retraction is required.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K132526 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132526: Knit-Pak+.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132526
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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