510(k) · Cleared
ClearedMitek Mini Anchor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mitek Surgical Products, Inc. · MNV Strip, Dialysate Ph Indicator
Cleared on Oct 31, 1995 after a 559-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 69 later devices descend from it.
- Decided
- Oct 31, 1995
- Review
- 559 days
- Class
- Class II
- Product code
- MNV
- Recalls
- None
- Predicates
- 0
69 later devices descend from it, 2 citing it directly.
- This deviceK936311 Mitek Mini AnchorMitek Surgical Products, Inc. · 1995
- Descendant · cites it directly · 67 of its ownK992487 Mitek Mini Quickanchor PlusMitek Products · 1999
- Descendant · 2 generations on · 50 of its ownK061349 Opus Labralock P Knotless Fixation DeviceArthrocare Corp. · 2006
- Descendant · 3 generations on · 27 of its ownK070227 Opus Magnum PI Knotless Fixation DeviceArthrocare Corp. · 2007
- Descendant · 3 generations on · 18 of its ownK090615 Opus Speedlock Knotless Fixation DeviceArthrocare Corp. · 2009 · Recalled
- Descendant · 4 generations on · 16 of its ownK081893 Opus Magnum Speedscrew Knotless Fixation Device, Model OM-6500Arthrocare Corp. · 2008
Showing 5 of 69 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 69 · See all- K992487Mitek Mini Quickanchor PlusMitek Products · 1999 · cites it directly67descendants
- K061349Opus Labralock P Knotless Fixation DeviceArthrocare Corp. · 2006 · 2 generations on50descendants
- K070227Opus Magnum PI Knotless Fixation DeviceArthrocare Corp. · 2007 · 3 generations on27descendants
- K090615Opus Speedlock Knotless Fixation DeviceArthrocare Corp. · 2009 · 3 generations on18descendants
- K081893Opus Magnum Speedscrew Knotless Fixation Device, Model OM-6500Arthrocare Corp. · 2008 · 4 generations on16descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K936311 | Mitek Mini Anchor | Mitek Surgical Products, Inc. | 1995 | — |
| +1 | K992487 | Mitek Mini Quickanchor Plus | Mitek Products | 1999 | — |
| +2 | K061349 | Opus Labralock P Knotless Fixation Device | Arthrocare Corp. | 2006 | — |
| +3 | K070227 | Opus Magnum PI Knotless Fixation Device | Arthrocare Corp. | 2007 | — |
| +3 | K090615 | Opus Speedlock Knotless Fixation Device | Arthrocare Corp. | 2009 | 1 |
| +4 | K081893 | Opus Magnum Speedscrew Knotless Fixation Device, Model OM-6500 | Arthrocare Corp. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2009 | 4 | 0 |
| 2010 | 4 | 0 |
| 2011 | 9 | 0 |
| 2012 | 5 | 0 |
| 2013 | 8 | 0 |
| 2014 | 4 | 0 |
| 2015 | 8 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 3 | 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 MNV? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (69)
See all 692 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, K992487 (Mitek Products, 1999) has gone furthest, with 67 descendants of its own.
How does its category compare?
All MNV devicesMNV Strip, Dialysate Ph Indicator: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MNV
1in 2011
2026 to Oct 25, outlined.
Median 510(k) review, days · MNV
Too few MNV 510(k)s in any year since 2007 to give a median.
Recalls per year · MNV
No recall names MNV since 2007.
Adverse event reports per year · MNV
No MAUDE report names MNV since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K936311 · printed Nov 6, 2026
Cite this page
510(k) Report. “K936311: Mitek Mini Anchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K936311
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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