510(k) · Cleared
ClearedSJM Rigid Saddle Ring Model Rsar-(Size)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
St. Jude Medical, Inc. · KRH Ring, Annuloplasty
Cleared on Dec 17, 2004 as substantially equivalent to K032250 (Edwards Lifesciences, LLC, 2003) after a 77-day review. Its family tree reaches back 3 generations to 1993.
- Decided
- Dec 17, 2004
- Review
- 77 days
- Class
- Class II
- Product code
- KRH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K923367 (1993). 4 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 deviceK042734 SJM Rigid Saddle Ring Model Rsar-(Size)St. Jude Medical, Inc. · 2004
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) | K042734 | SJM Rigid Saddle Ring Model Rsar-(Size) | St. Jude Medical, Inc. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 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? (2)
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…ral Repair Ring Classification: Class IIper 21 CFR 870.3800, Annuloplasty rings Predicate Device: K032250-Edwards Lifesciences GeoFormTM annuloplasty ring model 4200 (Carpentier- McCarthy-Adams IMR-ETIogix annuloplasty ring model 4100… | 2003 |
| * | — | Carpentier-McCarthy-Adams IMR-Etiologix annuloplasty ring model 4100 Named without a submission number |
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 11 years and passes through 3 companies; a new generation was cleared every 1.4 years on median.
- None of the 4 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.
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 SJMT M Rigid Saddle ring is indicated for use to correct annular dilation, increase leaflet coaptation, and prevent further dilatation of the mitral valve annulus caused by diseased states such as degenerative disease, rheumatic disease, Ischemia or vascular disease. The combination of prosthetic ring with valvuloplasty may be used in all acquired or congenital mitral insufficiencies with dilation and deformation of the fibrous mitral annulus. For…
Read the full statement (131 words)
The SJMT M Rigid Saddle ring is indicated for use to correct annular dilation, increase leaflet coaptation, and prevent further dilatation of the mitral valve annulus caused by diseased states such as degenerative disease, rheumatic disease, Ischemia or vascular disease. The combination of prosthetic ring with valvuloplasty may be used in all acquired or congenital mitral insufficiencies with dilation and deformation of the fibrous mitral annulus.
For mitral insufficiencies with no subvalvular lesions and normal valvular movements, prosthetic ring implant along may be sufficient. However, annuloplasty ring implant along with mitral valvuloplasty repair must be considered for insufficiencies with a prolapsed valve due to elongation or rupture of the chordae tendineae and for insufficiencies with limitation of valvular movements due to fusion of the commisures or chordae tendineae, or chordal hypertrophy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042734 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042734: SJM Rigid Saddle Ring Model Rsar-(Size).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042734
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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