510(k) · Cleared
ClearedAnnuloflo System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carbomedics, Inc. · KRH Ring, Annuloplasty
Cleared on Jul 25, 1997 after a 172-day review. The FDA summary names its predicate without a number. 5 later devices descend from it.
- Decided
- Jul 25, 1997
- Review
- 172 days
- Class
- Class II
- Product code
- KRH
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK970375 Annuloflo SystemCarbomedics, Inc. · 1997
- Descendant · cites it directly · 4 of its ownK071327 Memo 3D Semirigid Annuloplasty RingSorin Biomedica Cardio S.R.L. · 2007
- Descendant · 2 generations on · 3 of its ownK142221 MEMO 3D ReChordSorin Group Italia S.R.L. · 2014
- Descendant · 3 generations on · 2 of its ownK180411 MEMO 4DSorin Group Italia S.R.L. · 2018
- Descendant · 2 generations on · 1 of its ownK230318 Memo 3D Semirigid Annuloplasty Ring; Memo 3D ReChord Semirigid…Corcym S.r.l. · 2023
- Descendant · 3 generations on · 0 of its ownK261707 MEMO 4D Curve™ Semirigid mitral annuloplasty ringCorcym S.r.l. · 2026
Most influential descendants
Showing 5 of 5 · See all- K071327Memo 3D Semirigid Annuloplasty RingSorin Biomedica Cardio S.R.L. · 2007 · cites it directly4descendants
- K142221MEMO 3D ReChordSorin Group Italia S.R.L. · 2014 · 2 generations on3descendants
- K180411MEMO 4DSorin Group Italia S.R.L. · 2018 · 3 generations on2descendants
- K230318Memo 3D Semirigid Annuloplasty Ring; Memo 3D ReChord Semirigid Annuloplasty Ring; Memo…Corcym S.r.l. · 2023 · 2 generations on1descendant
- K261707MEMO 4D Curve™ Semirigid mitral annuloplasty ringCorcym S.r.l. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K970375 | Annuloflo System | Carbomedics, Inc. | 1997 | — |
| +1 | 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 | — |
| +3 | K180411 | MEMO 4D | Sorin Group Italia S.R.L. | 2018 | — |
| +2 | K230318 | Memo 3D Semirigid Annuloplasty Ring; Memo 3D ReChord Semirigid Annuloplasty… | Corcym S.r.l. | 2023 | — |
| +3 | K261707 | MEMO 4D Curve™ Semirigid mitral annuloplasty ring | Corcym S.r.l. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | — | Carpentier-Edwards Classic™ Annuloplasty Ring Named without a submission number |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071327 | Memo 3D Semirigid Annuloplasty Ring | 2007 | 4 |
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?
- Of its descendants, K071327 (Sorin Biomedica Cardio S.R.L., 2007) has gone furthest, with 4 descendants of its own.
How does its category compare?
All KRH devicesKRH Ring, Annuloplasty: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
The AnnuloFlo™ annuloplasty ring is indicated as a reinforcement: for repair of the human’ cardiac mitral valve damaged by acquired or congenital disease, or as a replacement for a previously implanted annuloplasty ring. The annuloplasty ring should be used only in cases where visual inspection confirms that the valve is repairable and does not require replacement.
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/K970375 · printed Nov 4, 2026
Cite this page
510(k) Report. “K970375: Annuloflo System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970375
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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