510(k) · Cleared
Recalled · Class II · 2016Chord-X Pre-Measured Loops for Mitral Chordal Replacement
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
On-X Life Technologies, Inc. · PAW Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement
Cleared on Jun 6, 2014 as substantially equivalent to K953289 (Davis & Geck, Inc., 1995) after a 43-day review. Its family tree reaches back 1 generation to 1995. 1 later device descends from it. It has been recalled once.
- Decided
- Jun 6, 2014
- Review
- 43 days
- Class
- Class II
- Product code
- PAW
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K953289 (1995). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK953289 Tetrafluoroethylene (Tfe) Polymer PledgetDavis & Geck, Inc. · 1995
- This deviceK141060 Chord-X Pre-Measured Loops for Mitral Chordal ReplacementOn-X Life Technologies, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK252126 MitraPatch Mitral Valve Repair SystemChawla Heart Technologies, LLC · 2025
Most influential descendants
Showing 1 of 1 · See all- K252126MitraPatch Mitral Valve Repair SystemChawla Heart Technologies, LLC · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K953289 | Tetrafluoroethylene (Tfe) Polymer Pledget | Davis & Geck, Inc. | 1995 | — |
| 0 (this device) | K141060 | Chord-X Pre-Measured Loops for Mitral Chordal Replacement | On-X Life Technologies, Inc. | 2014 | — |
| +1 | K252126 | MitraPatch Mitral Valve Repair System | Chawla Heart Technologies, LLC | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
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.
Top candidate predicates for a new PAW device
- #1 K252126 MitraPatch Mitral Valve Repair Systemscore 10.8 · 2 generations · no Class I recall
What was it cleared against? (2)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K021173 | Chord-X ePTFE Suture Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | |
| * | K953289 | Tetrafluoroethylene (Tfe) Polymer PledgetSummary page 5…78.5035 Product code: PAW Class: Il Substantial Equivalence: Chord-X ePTFE Suture - KI21173 - On-X Life Technologies, Inc. Tetraflouroethylene (TFE) Polymer Pledget - K953289 - Davis and Geck - Now Covidien Device Description The device is a non-absorbable monofilament ePTFE suture using 4 Chord-X ePT… | 1995 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K252126 | MitraPatch Mitral Valve Repair System | 2025 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 13, 2016 | Class II | Z-1057-2017 | Component design/selection | Four issues were uncovered by the recalling firm's CAPA: 1) Burrs were found to be present on Left Housing, Right Housing and Barrel components, 2) Loose plastic particulate was found within sealed primary packages, 3) Loose hair was… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K252126 (Chawla Heart Technologies, LLC, 2025) has gone furthest, with 0 descendants of its own.
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. 2014, 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?
Chord-X Pre-Measured Loops for Mitral Chordal Replacement are indicated for the
repair or replacement of chordae tendinae.
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/K141060 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141060: Chord-X Pre-Measured Loops for Mitral Chordal Replacement.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141060
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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