PMA · Approved
Recalled · Class I · 2016Mitraclip Delivery System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Medical · NKM Mitral Valve Repair Devices
Approved on Oct 24, 2013 through premarket approval, which rests on the device’s own clinical evidence after a 1,330-day review. It has a Class I recall. It has been recalled once, including a Class I recall.
- Decided
- Oct 24, 2013
- Review
- 1,330 days
- Class
- Class III
- Product code
- NKM
- Recalls
- 1 (1 Class I)
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P100009 has 82 supplements since 2014: changes to the approved device, its labelling or its manufacturing, each approved separately.
PMA supplements approved per year
View FIG. 1 as a table
| Year | Supplements approved |
|---|---|
| 2014 | 8 |
| 2015 | 5 |
| 2016 | 6 |
| 2017 | 4 |
| 2018 | 3 |
| 2019 | 9 |
| 2020 | 1 |
| 2021 | 5 |
| 2022 | 6 |
| 2023 | 11 |
| 2024 | 8 |
| 2025 | 11 |
| 2026 | 5 |
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. 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
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 4, 2016 | Class I | Z-0911-2016 | Use error | Abbott Vascular has recently received reports of cases on Clip Delivery System devices that contain the One-Way Actuator Knob where a user attempted implanting a MitraClip, but the Clip could not be detached from the delivery system due… |
No ancestor or descendant has a Class I recall.
How does its category compare?
All NKM devicesNKM Mitral Valve Repair Devices: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · NKM
16in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NKM
Too few NKM 510(k)s in any year since 2007 to give a median.
Recalls per year · NKM
3in 2022
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · NKM
2,833in 2025
MAUDE reports naming product code NKM, 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 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 1 | — | 0 | 40 |
| 2014 | 8 | — | 0 | 484 |
| 2015 | 5 | — | 0 | 544 |
| 2016 | 6 | — | 1 (1) | 826 |
| 2017 | 4 | — | 0 | 1,138 |
| 2018 | 3 | — | 0 | 1,668 |
| 2019 | 9 | — | 0 | 2,278 |
| 2020 | 1 | — | 0 | 2,724 |
| 2021 | 5 | — | 0 | 2,346 |
| 2022 | 12 | — | 3 | 2,584 |
| 2023 | 20 | — | 0 | 2,475 |
| 2024 | 15 | — | 0 | 2,562 |
| 2025 | 16 | — | 0 | 2,833 |
| 2026 | 11 | — | 0 | — |
https://510kreport.com/device/P100009 · printed Nov 6, 2026
Cite this page
510(k) Report. “P100009: Mitraclip Delivery System.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P100009
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026