510(k) · Cleared
ClearedDetlogix Annuloplasty Ring, Model: 5100
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Edwards Lifesciences, LLC · KRH Ring, Annuloplasty
Cleared on Apr 10, 2009 as substantially equivalent to K032250 (Edwards Lifesciences, LLC, 2003) and 2 other predicates after a 163-day review. Its family tree reaches back 3 generations to 1993.
- Decided
- Apr 10, 2009
- Review
- 163 days
- Class
- Class II
- Product code
- KRH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K923367 (1993). 5 ancestors in all, the oldest K831949 (1983). No later device cites it as a predicate yet.
- Root · 3 generations backK923367 Cosgrove Edwards Annuloplasty System, Model 4600Baxter Healthcare Corp · 1993
- 2 generations backK020864 Edwards MC Tricuspid Annuloplasty System, Model 4900Edwards Lifesciences, LLC · 2002
- 1 generation backK032250 Geoform Annuloplasty Ring, Mitral Model 4200Edwards Lifesciences, LLC · 2003
- This deviceK083191 Detlogix Annuloplasty Ring, Model: 5100Edwards Lifesciences, LLC · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K923367 | Cosgrove Edwards Annuloplasty System, Model 4600 | Baxter Healthcare Corp | 1993 | — |
| −2 | K020864 | Edwards MC Tricuspid Annuloplasty System, Model 4900 | Edwards Lifesciences, LLC | 2002 | — |
| −1 | K032250 | Geoform Annuloplasty Ring, Mitral Model 4200 | Edwards Lifesciences, LLC | 2003 | — |
| 0 (this device) | K083191 | Detlogix Annuloplasty Ring, Model: 5100 | Edwards Lifesciences, LLC | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1993 | 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 |
|---|---|---|---|
| * | K032250 | Geoform Annuloplasty Ring, Mitral Model 4200Summary page 1…Tlog iXT m annuloplasty ring Classification Name: Class II,CFR 870.3800 Annuloplasty Ring, KRH Predicate Device(s): CeoForm® annuloplasty ring (K032250) Carpentier-Edwards Physio® annuloplasty ring (K9261 38)… | 2003 |
| * | K926138 | Carpentier-Edwards Physio Annuloplasty RingSummary page 1…e(s): CeoForm® annuloplasty ring (K032250) Carpentier-Edwards Physio® annuloplasty ring (K9261 38) Carpentier-Edwards Classico annuloplasty ring (K831 949) Dev… | 1993 |
| * | K831949 | Prosthetic Rings #4400 Mitral & 4500Summary page 1…asty ring (K9261 38) Carpentier-Edwards Classico annuloplasty ring (K831 949) Device Description: The dETlogiXTm annuloplasty ring, model 5100, is constructed… | 1983 |
What descends from it?
No later submission names this one as a predicate yet.
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 16 years and passes through 2 companies; a new generation was cleared every 5.6 years on median.
- None of the 5 ancestors has a recall.
- 2 other devices also cite its predicate K032250.
How does its category compare?
All KRH devicesKRH Ring, Annuloplasty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
The dETIogix annuloplasty ring, model 51 00, is indicated for the correction of mitral valvular insufficiency where the lesions are not severe enough as to require total valve replacement. The decision to undertake valvuloplasty can be made only after visual analysis of the lesion present. The most favorable conditions for valvuloplasty using an annuloplasty ring are a combination of a distended natural valve ring associated with supple valve cusps and…
Read the full statement (170 words)
The dETIogix annuloplasty ring, model 51 00, is indicated for the correction of mitral valvular insufficiency where the lesions are not severe enough as to require total valve replacement.
The decision to undertake valvuloplasty can be made only after visual analysis of the lesion present. The most favorable conditions for valvuloplasty using an annuloplasty ring are a combination of a distended natural valve ring associated with supple valve cusps and normal chordae tendineae.
The remodeling valvuloplasty technique with a prosthetic ring may be used in all acquired or congenital mitral insufficiencies with dilatation and deformation of the fibrous mitral annulus.
For Type I mitral insufficiencies with no subvalvular lesions and normal valvular movements, this ring technique used alone is sufficient. However, the ring technique must be associated with mitral valvuloplasty repair in Type II insufficiencies with a prolapsed valve due to elongation or rupture of the chordae tendineae and in Type III insufficiencies with limitation of valvular movements due to fusion of the commissures or chordae tendineae, or chordal hypertrophy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083191 · printed Nov 3, 2026
Cite this page
510(k) Report. “K083191: Detlogix Annuloplasty Ring, Model: 5100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K083191
Report an extraction error
Are you the manufacturer?
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