510(k) · Cleared
ClearedUniring - Annuloplasty Ring with Sizers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Peters Surgical · KRH Ring, Annuloplasty
Cleared on Aug 3, 2007 as substantially equivalent to K033685 (Medical Cv, Inc., 2004) and 3 other predicates after an 88-day review. Its family tree reaches back 2 generations to 1993.
- Decided
- Aug 3, 2007
- Review
- 88 days
- Class
- Class II
- Product code
- KRH
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K923367 (1993). 4 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K923367 | Cosgrove Edwards Annuloplasty System, Model 4600 | Baxter Healthcare Corp | 1993 | — |
| −1 | K033685 | Northrup Universal Annuloplasty System, Model 1000 | Medical Cv, Inc. | 2004 | — |
| 0 (this device) | K071281 | Uniring - Annuloplasty Ring with Sizers | Peters Surgical | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1999 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K033685 | Northrup Universal Annuloplasty System, Model 1000Summary page 2…ition. For purposes of this submission, the UN1R1NG® was compared to the following predicate device(s): * Northrup Universal Annuloplasty System - K033685 CarboMedics AnnuloFlex Annuloplast¥ System- K992056 can be implanted either as a partial… | 2004 |
| * | K992056 | Annuloflex Annuloplasty System, Model AF800Summary page 2…pared to the following predicate device(s): * Northrup Universal Annuloplasty System - K033685 CarboMedics AnnuloFlex Annuloplast¥ System- K992056 can be implanted either as a partial or complete ring with identical function as… | 1999 |
| * | K923367 | Cosgrove Edwards Annuloplasty System, Model 4600Summary page 2…with identical function as the Northrup Universal Annuloplasty System * Edwards Lifesciences Cosgrove-Edwards Annuloplasty System - K923367 * Baxter Capentier-Edwards Physio Annuloplasty Ring- K926138 Performance data Non-clinical laboratory te… | 1993 |
| * | K926138 | Carpentier-Edwards Physio Annuloplasty RingSummary page 2…nnuloplasty System * Edwards Lifesciences Cosgrove-Edwards Annuloplasty System - K923367 * Baxter Capentier-Edwards Physio Annuloplasty Ring- K926138 Performance data Non-clinical laboratory testing was performed demonstrating that the device complied with the USP… | 1993 |
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 14 years and passes through 3 companies; a new generation was cleared every 11.6 years on median.
- None of the 4 ancestors has a recall.
How does its category compare?
All KRH devicesKRH 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
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 UNIRING® is indicated as reinforcement for repair of the human cardiac mitral and tricuspid valves 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 as stated in the FDA summary.
https://510kreport.com/device/K071281 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071281: Uniring - Annuloplasty Ring with Sizers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071281
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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