510(k) Report

510(k) · Cleared

Cleared

Memo 3D Semirigid Annuloplasty Ring

K071327510(k) TraditionalCleared Aug 10, 200791-day reviewClass II21 CFR 870.3800

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Sorin Biomedica Cardio S.R.L. · KRH Ring, Annuloplasty

Cleared on Aug 10, 2007 as substantially equivalent to K926138 (Baxter Healthcare Corp, 1993) and 3 other predicates after a 91-day review. Its family tree reaches back 1 generation to 1993. 4 later devices descend from it.

Decided
Aug 10, 2007
Review
91 days
Class
Class II
Product code
KRH
Recalls
None
Predicates
4

Its longest line of descent runs back 1 generation to K926138 (1993). 4 ancestors in all. 4 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2002: 2 other ancestors1997: 1 other ancestor2014: 1 descendant cleared2023: 1 descendant cleared2018: 1 descendant cleared2026: 1 descendant clearedK926138 · Carpentier-Edwards Physio Annuloplasty Ring · Baxter Healthcare Corp · 19931990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors 1 generation forward: 2 descendants2 generations forward: 2 descendants K926138 · Carpentier-Edwards Physio Annuloplasty Ring · Baxter Healthcare Corp · 19930
  1. Root · 1 generation backK926138 Carpentier-Edwards Physio Annuloplasty RingBaxter Healthcare Corp · 1993
  2. This deviceK071327 Memo 3D Semirigid Annuloplasty RingSorin Biomedica Cardio S.R.L. · 2007
  3. Descendant · cites it directly · 3 of its ownK142221 MEMO 3D ReChordSorin Group Italia S.R.L. · 2014
  4. Descendant · 2 generations on · 2 of its ownK180411 MEMO 4DSorin Group Italia S.R.L. · 2018
  5. Descendant · cites it directly · 1 of its ownK230318 Memo 3D Semirigid Annuloplasty Ring; Memo 3D ReChord Semirigid…Corcym S.r.l. · 2023
  6. Descendant · 2 generations on · 0 of its ownK261707 MEMO 4D Curve™ Semirigid mitral annuloplasty ringCorcym S.r.l. · 2026

Most influential descendants

Showing 4 of 4 · See all
  • K142221MEMO 3D ReChordSorin Group Italia S.R.L. · 2014 · cites it directly3descendants
  • K180411MEMO 4DSorin Group Italia S.R.L. · 2018 · 2 generations on2descendants
  • K230318Memo 3D Semirigid Annuloplasty Ring; Memo 3D ReChord Semirigid Annuloplasty Ring; Memo…Corcym S.r.l. · 2023 · cites it directly1descendant
  • K261707MEMO 4D Curve™ Semirigid mitral annuloplasty ringCorcym S.r.l. · 2026 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K926138Carpentier-Edwards Physio Annuloplasty RingBaxter Healthcare Corp1993—
0 (this device)K071327Memo 3D Semirigid Annuloplasty RingSorin Biomedica Cardio S.R.L.2007—
+1K142221MEMO 3D ReChordSorin Group Italia S.R.L.2014—
+2K180411MEMO 4DSorin Group Italia S.R.L.2018—
+1K230318Memo 3D Semirigid Annuloplasty Ring; Memo 3D ReChord Semirigid Annuloplasty…Corcym S.r.l.2023—
+2K261707MEMO 4D Curve™ Semirigid mitral annuloplasty ringCorcym S.r.l.2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199710
200220

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
201810
202310
202610
FIG. 1 — Lineage of K071327, 1993–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K261707 MEMO 4D Curve™ Semirigid mitral annuloplasty…score 12.7 · 5 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (4)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K926138Carpentier-Edwards Physio Annuloplasty Ring
Summary page 1
…: Annuloplasty Ring * Product Code: KRH - Class II - Special Controls * Medical Specialty: Cardiovascular Predicate a K926138: Baxter Healthcare Corporation Carpentier-Edwards Physio Devices Annuloplasty Ring * K970375 and K…
Baxter Healthcare Corp1993—
*K970375Annuloflo System
Summary page 1
…ecialty: Cardiovascular Predicate a K926138: Baxter Healthcare Corporation Carpentier-Edwards Physio Devices Annuloplasty Ring * K970375 and K021051: Carbomedics AnnuloFloTM System *1 K023185: Carbomedics AnnuloFlexTM Annuloplasty System…
Carbomedics, Inc.1997—
*K021051Annuloflo System, Mitral Model AR700
Summary page 1
…diovascular Predicate a K926138: Baxter Healthcare Corporation Carpentier-Edwards Physio Devices Annuloplasty Ring * K970375 and K021051: Carbomedics AnnuloFloTM System *1 K023185: Carbomedics AnnuloFlexTM Annuloplasty System…
Sulzer Carbomedics, Inc.2002—
*K023185Annuloflex Annuoplasty System, Model AF 800
Summary page 1
…Corporation Carpentier-Edwards Physio Devices Annuloplasty Ring * K970375 and K021051: Carbomedics AnnuloFloTM System *1 K023185: Carbomedics AnnuloFlexTM Annuloplasty System…
Sulzer Carbomedics, Inc.2002—

Also cleared against K926138: 6 other devices →

What descends from it? (4)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K142221MEMO 3D ReChordSorin Group Italia S.R.L.20143
K230318Memo 3D Semirigid Annuloplasty Ring; Memo 3D ReChord Semirigid Annuloplasty Ring; Memo…Corcym S.r.l.20231

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?

  • None of the 4 ancestors has a recall.
  • Of its descendants, K142221 (Sorin Group Italia S.R.L., 2014) has gone furthest, with 3 descendants of its own.
  • 6 other devices also cite its predicate K926138.

How does its category compare?

All KRH devices

KRH Ring, Annuloplasty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · KRH

4in 2025

2007: 42008: 22009: 82010: 22011: 22014: 12016: 12018: 22019: 22020: 22023: 22024: 12025: 42026 (partial year): 2
2007high 8 (2009) · low 0 (2012)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KRH

98in 2025

2007: 90 days median2009: 68 days median2025: 98 days median
2007high 98 (2025) · low 68 (2009)2026

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

2007: 2612008: 1,2882009: 9732010: 6302011: 3212012: 902013: 972014: 732015: 1452016: 3472017: 3792018: 3782019: 3492020: 3402021: 4232022: 3722023: 3242024: 4072025: 420
2007high 1,288 (2008) · low 73 (2014)2025

MAUDE reports naming product code KRH, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20074900261
20082—01,288
20098680973
20102—0630
20112—0321
20120—090
20130—097
20141—073
20150—0145
20161—0347
20170—0379
20182—0378
20192—0349
20202—0340
20210—0423
20220—0372
20232—0324
20241—0407
20254980420
20262—0—

What is it indicated for?

MEMO 3DTM device is intended for correction of mitral insufficiencies or sten- insufficiencies. The use of the MEMO 3DTM 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 device on its own. For type II insufficiencies, characterized by valve prolapse sustained by…

Read the full statement (102 words)

MEMO 3DTM device is intended for correction of mitral insufficiencies or sten- insufficiencies.

The use of the MEMO 3DTM 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 device on its own. For type II insufficiencies, characterized by valve prolapse sustained by elongation/breakage of the chordae tendineae and papillary muscles, and type III insufficiencies, characterized by partially immobilized 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.

Also cleared against K926138

6 other devices cite the same predicate.

  • K251688Carpentier-Edwards Physio Annuloplasty Ring (4450)Edwards Lifesciences, LLC · 2025
  • K083623Carpentier-Mccarthy-Adams Imr Etlogix Annuloplasty Ring, Model 4100Edwards Lifesciences, LLC · 2009
  • K083191Detlogix Annuloplasty Ring, Model: 5100Edwards Lifesciences, LLC · 2009
  • K083470Carpentier- Edwards Physio II Annuloplasty, Model 5200Edwards Lifesciences, LLC · 2009
  • K071281Uniring - Annuloplasty Ring with SizersPeters Surgical · 2007
  • K033685Northrup Universal Annuloplasty System, Model 1000Medical Cv, Inc. · 2004

Recent decisions in KRH

The KRH category page

  • K261707MEMO 4D Curve™ Semirigid mitral annuloplasty ringCorcym S.r.l. · 2026
  • K260498TriMemo™ SEMIRIGID ANNULOPLASTY RINGCorcym S.r.l. · 2026
  • K253232Seguin Annuloplasty RingAbbott Medical · 2025
  • K251982Edwards MC3 Tricuspid annuloplasty ring (4900)Edwards Lifesciences, LLC · 2025
  • K251688Carpentier-Edwards Physio Annuloplasty Ring (4450)Edwards Lifesciences, LLC · 2025

https://510kreport.com/device/K071327 · printed Nov 5, 2026

Cite this page

510(k) Report. “K071327: Memo 3D Semirigid Annuloplasty Ring.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071327

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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