510(k) Report

510(k) · Cleared

Cleared

Pti Annuloplasty Ring (Sterile)

K905175510(k) TraditionalCleared Feb 14, 1992452-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

Pioneering Technologies, Inc. · KRH Ring, Annuloplasty

Cleared on Feb 14, 1992 after a 452-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 10 later devices descend from it.

Decided
Feb 14, 1992
Review
452 days
Class
Class II
Product code
KRH
Recalls
None
Predicates
0

10 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2005: 2 descendants cleared2007: 2 descendants cleared1999: 1 descendant cleared2020: 1 descendant cleared2010: 1 descendant cleared2024: 1 descendant cleared2023: 1 descendant cleared2025: 1 descendant cleared1990200020102020
  1. This deviceK905175 Pti Annuloplasty Ring (Sterile)Pioneering Technologies, Inc. · 1992
  2. Descendant · cites it directly · 5 of its ownK072655 Ats Simulus Semi-Rigid Mitral Annuloplasty Ring, Model 800SRGenesee Biomedical, Inc. · 2007
  3. Descendant · cites it directly · 2 of its ownK052565 Ats Simulus Annuloplasty Ring, Model 700FFGenesee Biomedical, Inc. · 2005
  4. Descendant · 2 generations on · 1 of its ownK232599 TransForm McCarthy Mitral Annuloplasty Ring (TF)Genesee Biomedical, Inc. · 2024
  5. Descendant · 2 generations on · 1 of its ownK093903 Ats Tri-AD Semi-Flexible Tricuspid Anuuloplasty, Model 900SFCGenesee Biomedical, Inc. · 2010
  6. Descendant · cites it directly · 1 of its ownK052899 Ats Simulus Annuloplasty Band, Model 700FCGenesee Biomedical, Inc. · 2005

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

1999: 12005: 22007: 22010: 12020: 12023: 12024: 12025: 1
1999high 2 (2005) · low 0 (2000)2026

Most influential descendants

Showing 5 of 10 · See all
  • K072655Ats Simulus Semi-Rigid Mitral Annuloplasty Ring, Model 800SRGenesee Biomedical, Inc. · 2007 · cites it directly5descendants
  • K052565Ats Simulus Annuloplasty Ring, Model 700FFGenesee Biomedical, Inc. · 2005 · cites it directly2descendants
  • K232599TransForm McCarthy Mitral Annuloplasty Ring (TF)Genesee Biomedical, Inc. · 2024 · 2 generations on1descendant
  • K093903Ats Tri-AD Semi-Flexible Tricuspid Anuuloplasty, Model 900SFCGenesee Biomedical, Inc. · 2010 · 2 generations on1descendant
  • K052899Ats Simulus Annuloplasty Band, Model 700FCGenesee Biomedical, Inc. · 2005 · cites it directly1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K905175Pti Annuloplasty Ring (Sterile)Pioneering Technologies, Inc.1992—
+1K072655Ats Simulus Semi-Rigid Mitral Annuloplasty Ring, Model 800SRGenesee Biomedical, Inc.2007—
+1K052565Ats Simulus Annuloplasty Ring, Model 700FFGenesee Biomedical, Inc.2005—
+2K232599TransForm McCarthy Mitral Annuloplasty Ring (TF)Genesee Biomedical, Inc.2024—
+2K093903Ats Tri-AD Semi-Flexible Tricuspid Anuuloplasty, Model 900SFCGenesee Biomedical, Inc.2010—
+1K052899Ats Simulus Annuloplasty Band, Model 700FCGenesee Biomedical, Inc.2005—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
200520
200720
201010
202010
202310
202410
202510
FIG. 1 — Lineage of K905175, 1992–2025Source: 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? (10)

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K072655Ats Simulus Semi-Rigid Mitral Annuloplasty Ring, Model 800SRGenesee Biomedical, Inc.20075
K052565Ats Simulus Annuloplasty Ring, Model 700FFGenesee Biomedical, Inc.20052
K052899Ats Simulus Annuloplasty Band, Model 700FCGenesee Biomedical, Inc.20051
K071214Ats Simulus Adjustable Flexible Annuloplasty RingGenesee Biomedical, Inc.20070
K984435Medtronic Khonsari Annuloplasty Band, Model H609MMedtronic Vascular19990

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, K072655 (Genesee Biomedical, Inc., 2007) has gone furthest, with 5 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 Pioneering Technologies, Inc.

19 FDA decisions under this applicant name. See the company

  • K922025Anastomart (TM) Coronary Bypass Graft Markers/ModifPioneering Technologies, Inc. · 1992
  • K905068Pti Intra-Art (TM) Pick-UP WicksPioneering Technologies, Inc. · 1991
  • K910067Pti Sternal Closure Wire SuturePioneering Technologies, Inc. · 1991
  • K905067Pti Anastomark Flexible Coronary Bypass GraftPioneering Technologies, Inc. · 1991
  • K901682Pti Anastomark (TM) Coronary Bypass Graft MarkersPioneering Technologies, Inc. · 1990

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/K905175 · printed Nov 4, 2026

Cite this page

510(k) Report. “K905175: Pti Annuloplasty Ring (Sterile).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K905175

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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