510(k) · Cleared
ClearedMemo 3D Semirigid Annuloplasty Ring; Memo 3D ReChord Semirigid Annuloplasty Ring; Memo 4D Semirigid Annuloplasty Ring
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Corcym S.r.l. · KRH Ring, Annuloplasty
Cleared on Apr 7, 2023 as substantially equivalent to K071327 (Sorin Biomedica Cardio S.R.L., 2007) and 2 other predicates after a 60-day review. Its family tree reaches back 4 generations to 1993. 1 later device descends from it.
- Decided
- Apr 7, 2023
- Review
- 60 days
- Class
- Class II
- Product code
- KRH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K926138 (1993). 7 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK926138 Carpentier-Edwards Physio Annuloplasty RingBaxter Healthcare Corp · 1993
- 3 generations backK071327 Memo 3D Semirigid Annuloplasty RingSorin Biomedica Cardio S.R.L. · 2007
- 2 generations backK142221 MEMO 3D ReChordSorin Group Italia S.R.L. · 2014
- 1 generation backK180411 MEMO 4DSorin Group Italia S.R.L. · 2018
- This deviceK230318 Memo 3D Semirigid Annuloplasty Ring; Memo 3D ReChord Semirigid…Corcym S.r.l. · 2023
- Descendant · cites it directly · 0 of its ownK261707 MEMO 4D Curve™ Semirigid mitral annuloplasty ringCorcym S.r.l. · 2026
Most influential descendants
Showing 1 of 1 · See all- K261707MEMO 4D Curve™ Semirigid mitral annuloplasty ringCorcym S.r.l. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K926138 | Carpentier-Edwards Physio Annuloplasty Ring | Baxter Healthcare Corp | 1993 | — |
| −3 | K071327 | Memo 3D Semirigid Annuloplasty Ring | Sorin Biomedica Cardio S.R.L. | 2007 | — |
| −2 | K142221 | MEMO 3D ReChord | Sorin Group Italia S.R.L. | 2014 | — |
| −1 | K180411 | MEMO 4D | Sorin Group Italia S.R.L. | 2018 | — |
| 0 (this device) | K230318 | Memo 3D Semirigid Annuloplasty Ring; Memo 3D ReChord Semirigid Annuloplasty… | Corcym S.r.l. | 2023 | — |
| +1 | 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 |
|---|---|---|
| 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? (3)
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 |
|---|---|---|---|
| * | K071327 | Memo 3D Semirigid Annuloplasty RingSummary page 4…ified below. All devices have the same fundamental scientific technology and intended use: 510(k) Number: K071327, K142221, K180411 Proprietary Name: MEMO 3D Semirigid Annuloplasty Ring… | 2007 |
| * | K142221 | MEMO 3D ReChordSummary page 4…below. All devices have the same fundamental scientific technology and intended use: 510(k) Number: K071327, K142221, K180411 Proprietary Name: MEMO 3D Semirigid Annuloplasty Ring… | 2014 |
| * | K180411 | MEMO 4DSummary page 4…below. All devices have the same fundamental scientific technology and intended use: 510(k) Number: K071327, K142221, K180411 Proprietary Name: MEMO 3D Semirigid Annuloplasty Ring M… | 2018 |
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 |
|---|---|---|---|
| K261707 | MEMO 4D Curve™ Semirigid mitral annuloplasty ring | 2026 | 0 |
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 4 companies; a new generation was cleared every 7.1 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K261707 (Corcym S.r.l., 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K071327.
How does its category compare?
All KRH devicesKRH Ring, Annuloplasty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 3D device is indicated for use in patients suffering from congenital or acquired mitral insufficiencies or steno-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…
Read the full statement (294 words)
Memo 3D device is indicated for use in patients suffering from congenital or acquired mitral insufficiencies or steno-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.
The use of the MEMO 3D ReChord device is indicated for use in patients suffering from congenital or acquired mitral insufficiencies or steno-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.
The use of the Memo 4D device is indicated for use in patients suffering from congenital or acquired mitral insufficiencies or steno-insufficient 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/K230318 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230318: Memo 3D Semirigid Annuloplasty Ring; Memo 3D ReChord Semirigid Annuloplasty Ring; Memo 4D Semirigid Annuloplasty Ring.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230318
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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