510(k) · Cleared
ClearedHAART 300 Aortic Annuloplasty Device 19mm, HAART 300 Aortic Annuloplasty Device 21mm, HAART 300 Aortic Annuloplasty Device 23mm, HAART 300 Aortic Annuloplasty Device 25mm
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biostable Science & Engineering, Inc. · PST Aortic Annuloplasty Ring
Cleared on Mar 21, 2017 as substantially equivalent to K103520 (Edwards Lifesciences, LLC, 2011) after a 90-day review. Its family tree reaches back 3 generations to 1993. 1 later device descends from it.
- Decided
- Mar 21, 2017
- Review
- 90 days
- Class
- Class II
- Product code
- PST
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K923367 (1993). 4 ancestors in all, the oldest K912554 (1991). 1 later device descends from it, 1 citing it directly.
- 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 backK103520 Carpentier-Edwards Physio Tricuspid Annuloplasty RingEdwards Lifesciences, LLC · 2011
- This deviceK163608 HAART 300 Aortic Annuloplasty Device 19mm, HAART 300 Aortic…Biostable Science & Engineering, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK171431 HAART 200 Aortic Annuloplasty Device 19mm, HAART 200 Aortic…Biostable Science & Engineering, Inc. · 2017
Most influential descendants
Showing 1 of 1 · See all- K171431HAART 200 Aortic Annuloplasty Device 19mm, HAART 200 Aortic Annuloplasty Device 21mm…Biostable Science & Engineering, Inc. · 2017 · cites it directly0descendants
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 | K103520 | Carpentier-Edwards Physio Tricuspid Annuloplasty Ring | Edwards Lifesciences, LLC | 2011 | — |
| 0 (this device) | K163608 | HAART 300 Aortic Annuloplasty Device 19mm, HAART 300 Aortic Annuloplasty… | Biostable Science & Engineering, Inc. | 2017 | — |
| +1 | K171431 | HAART 200 Aortic Annuloplasty Device 19mm, HAART 200 Aortic Annuloplasty… | Biostable Science & Engineering, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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 PST? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K103520 | Carpentier-Edwards Physio Tricuspid Annuloplasty RingSummary page 4…21 CFR 870.3800 Product Code: PST Predicate Device: Carpentier-Edwards Physio Tricuspid Annuloplasty Ring, Model 6200 (K103520) Device Description The HAART 300 Aortic Annuloplasty Device is designed to return aortic annular geometry toward normal for a… | 2011 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171431 | HAART 200 Aortic Annuloplasty Device 19mm, HAART 200 Aortic Annuloplasty Device 21mm… | 2017 | 0 |
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 24 years and passes through 3 companies; a new generation was cleared every 9.2 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K171431 (Biostable Science & Engineering, Inc., 2017) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K103520.
How does its category compare?
All PST devicesPST Aortic Annuloplasty Ring: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · PST
2in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · PST
Too few PST 510(k)s in any year since 2007 to give a median.
Recalls per year · PST
No recall names PST since 2007.
Adverse event reports per year · PST
1in 2017
MAUDE reports naming product code PST, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 2 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The HAART 300 Aortic Annuloplasty Device is intended to be used to correct annular dilatation and/or maintain annular geometry of the aortic valve in patients with tri-leaflet valve morphology with moderate to severe aortic insufficiency who are undergoing aortic valve repair due to symptoms or as part of a repair for an aortic root aneurysm.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163608 · printed Nov 4, 2026
Cite this page
510(k) Report. “K163608: HAART 300 Aortic Annuloplasty Device 19mm, HAART 300 Aortic Annuloplasty Device 21mm, HAART 300 Aortic Annuloplasty Device 23mm, HAART 300 Aortic Annuloplasty Device 25mm.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K163608
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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