510(k) Report

510(k) · Cleared

Cleared

SJM Tailor Annuloplasty Ring, Model Tarn

K000119510(k) SpecialCleared Feb 17, 200030-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

St. Jude Medical, Inc. · KRH Ring, Annuloplasty

Cleared on Feb 17, 2000 after a 30-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.

Decided
Feb 17, 2000
Review
30 days
Class
Class II
Product code
KRH
Recalls
None
Predicates
0

4 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2002: 2 descendants cleared2009: 2 descendants cleared200020052010201520202025
  1. This deviceK000119 SJM Tailor Annuloplasty Ring, Model TarnSt. Jude Medical, Inc. · 2000
  2. Descendant · cites it directly · 3 of its ownK014161 SJM Tailor Annuloplasty Ring Model Tarp- (Size)St. Jude Medical, Inc. · 2002
  3. Descendant · 2 generations on · 1 of its ownK083835 Attune Adjustable Flexible Annuloplasty Ring Model AfrSt Jude Medical · 2009
  4. Descendant · 3 generations on · 0 of its ownK092876 SJM Attune Annuloplasty RingSt Jude Medical · 2009
  5. Descendant · 2 generations on · 0 of its ownK022363 SJM Tailor Annuloplasty Band, Model Tab-(Size) (Tailor Band)St. Jude Medical, Inc. · 2002

Most influential descendants

Showing 4 of 4 · See all
  • K014161SJM Tailor Annuloplasty Ring Model Tarp- (Size)St. Jude Medical, Inc. · 2002 · cites it directly3descendants
  • K083835Attune Adjustable Flexible Annuloplasty Ring Model AfrSt Jude Medical · 2009 · 2 generations on1descendant
  • K092876SJM Attune Annuloplasty RingSt Jude Medical · 2009 · 3 generations on0descendants
  • K022363SJM Tailor Annuloplasty Band, Model Tab-(Size) (Tailor Band)St. Jude Medical, Inc. · 2002 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K000119SJM Tailor Annuloplasty Ring, Model TarnSt. Jude Medical, Inc.2000—
+1K014161SJM Tailor Annuloplasty Ring Model Tarp- (Size)St. Jude Medical, Inc.2002—
+2K083835Attune Adjustable Flexible Annuloplasty Ring Model AfrSt Jude Medical2009—
+3K092876SJM Attune Annuloplasty RingSt Jude Medical2009—
+2K022363SJM Tailor Annuloplasty Band, Model Tab-(Size) (Tailor Band)St. Jude Medical, Inc.2002—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200220
200920
FIG. 1 — Lineage of K000119, 2000–2009Source: 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), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (4)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K014161SJM Tailor Annuloplasty Ring Model Tarp- (Size)St. Jude Medical, Inc.20023

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, K014161 (St. Jude Medical, Inc., 2002) has gone furthest, with 3 descendants of its own.

How does its category compare?

All KRH devices

KRH Ring, Annuloplasty: FDA decisions, review times, recalls and adverse event reports over 20 years.

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—

More from St. Jude Medical, Inc.

353 FDA decisions under this applicant name. See the company

  • K172393Advisor HD Grid Mapping Catheter, Sensor EnabledSt. Jude Medical, Inc. · 2018
  • K163407Confirm Rx Insertable Cardiac Monitor (ICM) SystemSt. Jude Medical, Inc. · 20174 recalls
  • K161171PressureWire X GuidewireSt. Jude Medical, Inc. · 2016
  • K161102Nanostim Introducer KitSt. Jude Medical, Inc. · 2016
  • K160716The Nanostim Introducer KitSt. Jude Medical, Inc. · 2016

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/K000119 · printed Nov 4, 2026

Cite this page

510(k) Report. “K000119: SJM Tailor Annuloplasty Ring, Model Tarn.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K000119

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026