510(k) · Cleared
ClearedMEMO 4D
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sorin Group Italia S.R.L. · KRH Ring, Annuloplasty
Cleared on Mar 16, 2018 as substantially equivalent to K142221 (Sorin Group Italia S.R.L., 2014) after a 29-day review. Its family tree reaches back 3 generations to 1993. 2 later devices descend from it.
- Decided
- Mar 16, 2018
- Review
- 29 days
- Class
- Class II
- Product code
- KRH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K926138 (1993). 6 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK926138 Carpentier-Edwards Physio Annuloplasty RingBaxter Healthcare Corp · 1993
- 2 generations backK071327 Memo 3D Semirigid Annuloplasty RingSorin Biomedica Cardio S.R.L. · 2007
- 1 generation backK142221 MEMO 3D ReChordSorin Group Italia S.R.L. · 2014
- This deviceK180411 MEMO 4DSorin Group Italia S.R.L. · 2018
- Descendant · cites it directly · 1 of its ownK230318 Memo 3D Semirigid Annuloplasty Ring; Memo 3D ReChord Semirigid…Corcym S.r.l. · 2023
- Descendant · 2 generations on · 0 of its ownK261707 MEMO 4D Curve™ Semirigid mitral annuloplasty ringCorcym S.r.l. · 2026
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K926138 | Carpentier-Edwards Physio Annuloplasty Ring | Baxter Healthcare Corp | 1993 | — |
| −2 | K071327 | Memo 3D Semirigid Annuloplasty Ring | Sorin Biomedica Cardio S.R.L. | 2007 | — |
| −1 | K142221 | MEMO 3D ReChord | Sorin Group Italia S.R.L. | 2014 | — |
| 0 (this device) | K180411 | MEMO 4D | Sorin Group Italia S.R.L. | 2018 | — |
| +1 | K230318 | Memo 3D Semirigid Annuloplasty Ring; Memo 3D ReChord Semirigid Annuloplasty… | Corcym S.r.l. | 2023 | — |
| +2 | K261707 | MEMO 4D Curve™ Semirigid mitral annuloplasty ring | Corcym S.r.l. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2002 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2026 | 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 KRH? 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 KRH device
- #1 K261707 MEMO 4D Curve™ Semirigid mitral annuloplasty…score 12.7 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K142221 | MEMO 3D ReChordSummary page 4…cleared predicate device identified below. Both devices have the same fundamental scientific technology and intended use: 510(k) Number: K142221 Proprietary Name: MEMO 3D ReChord Semirigid Annuloplasty Ring Common/Usual Name: Ring, Annuloplast… | 2014 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K230318 | Memo 3D Semirigid Annuloplasty Ring; Memo 3D ReChord Semirigid Annuloplasty Ring; Memo… | 2023 | 1 |
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 25 years and passes through 3 companies; a new generation was cleared every 7.1 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K230318 (Corcym S.r.l., 2023) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K142221.
How does its category compare?
All KRH devicesKRH Ring, Annuloplasty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · KRH
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KRH
98in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KRH
No recall names KRH since 2007.
Adverse event reports per year · KRH
420in 2025
MAUDE reports naming product code KRH, 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 | 4 | 90 | 0 | 261 |
| 2008 | 2 | — | 0 | 1,288 |
| 2009 | 8 | 68 | 0 | 973 |
| 2010 | 2 | — | 0 | 630 |
| 2011 | 2 | — | 0 | 321 |
| 2012 | 0 | — | 0 | 90 |
| 2013 | 0 | — | 0 | 97 |
| 2014 | 1 | — | 0 | 73 |
| 2015 | 0 | — | 0 | 145 |
| 2016 | 1 | — | 0 | 347 |
| 2017 | 0 | — | 0 | 379 |
| 2018 | 2 | — | 0 | 378 |
| 2019 | 2 | — | 0 | 349 |
| 2020 | 2 | — | 0 | 340 |
| 2021 | 0 | — | 0 | 423 |
| 2022 | 0 | — | 0 | 372 |
| 2023 | 2 | — | 0 | 324 |
| 2024 | 1 | — | 0 | 407 |
| 2025 | 4 | 98 | 0 | 420 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
Memo 4D device is intended for correction of mitral insufficiencies or steno-insufficiencies. The use of the Memo 4D device is indicated for correction of congenital or acquired mitral insufficiencies with dilatation and deformation of the mitral annulus. Type I insufficiencies, with no manifest lesions in the subvalvular apparatus, can be treated with the implant of the annuloplasty ring on its own. For type II insufficiencies, characterised by valve…
Read the full statement (106 words)
Memo 4D device is intended for correction of mitral insufficiencies or steno-insufficiencies.
The use of the Memo 4D device is indicated for correction of congenital or acquired mitral insufficiencies with dilatation and deformation of the mitral annulus. Type I insufficiencies, with no manifest lesions in the subvalvular apparatus, can be treated with the implant of the annuloplasty ring on its own. For type II insufficiencies, characterised by valve prolapse sustained by elongation/ breakage of the chordae tendineae and papillary muscles, and type III insufficiencies, characterised by partially immobilised leaflets due to the fusion/hypertrophy of the chordae tendineae, the device implantation must be accompanied by corrective valvuloplasty.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180411 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180411: MEMO 4D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180411
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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