510(k) · Cleared
ClearedMitraPatch Mitral Valve Repair System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Chawla Heart Technologies, LLC · PAW Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement
Cleared on Dec 4, 2025 as substantially equivalent to K141060 (On-X Life Technologies, Inc., 2014) after a 150-day review. Its family tree reaches back 2 generations to 1995.
- Decided
- Dec 4, 2025
- Review
- 150 days
- Class
- Class II
- Product code
- PAW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K953289 (1995). No later device cites it as a predicate yet.
- Root · 2 generations backK953289 Tetrafluoroethylene (Tfe) Polymer PledgetDavis & Geck, Inc. · 1995
- 1 generation backK141060 Chord-X Pre-Measured Loops for Mitral Chordal ReplacementOn-X Life Technologies, Inc. · 2014 · Recalled
- This deviceK252126 MitraPatch Mitral Valve Repair SystemChawla Heart Technologies, LLC · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K953289 | Tetrafluoroethylene (Tfe) Polymer Pledget | Davis & Geck, Inc. | 1995 | — |
| −1 | K141060 | Chord-X Pre-Measured Loops for Mitral Chordal Replacement | On-X Life Technologies, Inc. | 2014 | 1 |
| 0 (this device) | K252126 | MitraPatch Mitral Valve Repair System | Chawla Heart Technologies, LLC | 2025 | — |
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 PAW? 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? (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 |
|---|---|---|---|
| * | K141060 | Chord-X Pre-Measured Loops for Mitral Chordal ReplacementSummary page 5…hnologies, Inc. Chord-X Pre- Predicate Device Measured Loops for Mitral Chordal Replacement (K141060) Indication for Use: The MitraPatch is indicated to be used in the repair and replacement of marginal (primary) chordae tendinae… | 2014 |
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 30 years and passes through 3 companies; a new generation was cleared every 18.8 years on median.
- 1 of the 2 ancestors has a recall of any class.
How does its category compare?
All PAW devicesPAW Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · PAW
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PAW
Too few PAW 510(k)s in any year since 2007 to give a median.
Recalls per year · PAW
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PAW
4in 2025
MAUDE reports naming product code PAW, 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 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 1 | 2 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 1 | — | 0 | 4 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The MitraPatch is indicated to be used in the repair and replacement of marginal (primary) chordae tendinae only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252126 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252126: MitraPatch Mitral Valve Repair System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252126
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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