510(k) Report

510(k) · Cleared

Cleared

SJM Tailor Annuloplasty Band, Model Tab-(Size) (Tailor Band)

K022363510(k) SpecialCleared Sep 19, 200259-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 Sep 19, 2002 as substantially equivalent to K014161 (St. Jude Medical, Inc., 2002) after a 59-day review. Its family tree reaches back 2 generations to 2000.

Decided
Sep 19, 2002
Review
59 days
Class
Class II
Product code
KRH
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K000119 (2000). No later device cites it as a predicate yet.

K000119 · SJM Tailor Annuloplasty Ring, Model Tarn · St. Jude Medical, Inc. · 2000K014161 · SJM Tailor Annuloplasty Ring Model Tarp- (Size) · St. Jude Medical, Inc. · 2002200020022004
K014161 · SJM Tailor Annuloplasty Ring Model Tarp- (Size) · St. Jude Medical, Inc. · 2002K000119 · SJM Tailor Annuloplasty Ring, Model Tarn · St. Jude Medical, Inc. · 20000
  1. Root · 2 generations backK000119 SJM Tailor Annuloplasty Ring, Model TarnSt. Jude Medical, Inc. · 2000
  2. 1 generation backK014161 SJM Tailor Annuloplasty Ring Model Tarp- (Size)St. Jude Medical, Inc. · 2002
  3. This deviceK022363 SJM Tailor Annuloplasty Band, Model Tab-(Size) (Tailor Band)St. Jude Medical, Inc. · 2002
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K000119SJM Tailor Annuloplasty Ring, Model TarnSt. Jude Medical, Inc.2000—
−1K014161SJM Tailor Annuloplasty Ring Model Tarp- (Size)St. Jude Medical, Inc.2002—
0 (this device)K022363SJM Tailor Annuloplasty Band, Model Tab-(Size) (Tailor Band)St. Jude Medical, Inc.2002—
FIG. 1 — Lineage of K022363, 2000–2002Source: 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), 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. #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
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K014161SJM Tailor Annuloplasty Ring Model Tarp- (Size)
Summary page 2
…acteristics I Identical D. Summary of Non-Clinical Tests The testing for the Tailor ring model TARP (predicate) is included in the premarket notification (K014161). The following tests have been performed on the Tailor band model TAB to insure substantial equivalence with the predicate. 1.…
St. Jude Medical, Inc.2002—

Also cleared against K014161: 1 other device →

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 2 years and passes through 1 company; a new generation was cleared every 1.9 years on median.
  • None of the 2 ancestors has a recall.
  • 1 other device also cites its predicate K014161.

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—

What is it indicated for?

The SJMB Tailor annuloplasty band is indicated for use in repair of a mitral or tricuspid heart valve that is diseased or damaged due to acquired or congenital processes.

Indications for use as stated in the FDA summary.

Also cleared against K014161

1 other device cites the same predicate.

  • K083835Attune Adjustable Flexible Annuloplasty Ring Model AfrSt Jude Medical · 2009

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/K022363 · printed Nov 4, 2026

Cite this page

510(k) Report. “K022363: SJM Tailor Annuloplasty Band, Model Tab-(Size) (Tailor Band).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K022363

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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