510(k) Report

FDA applicant

Biostable Science & Engineering, Inc.

Austin, TX2 decisions2017–20170 recalls

FDA records 2 decisions for Biostable Science & Engineering, Inc. (Austin, TX) in 2017: 2 510(k) clearances. All are in product code PST (Aortic Annuloplasty Ring). Its devices cite 2 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Biostable Science & Engineering, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2017

2017: 2
2017high 2 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Biostable Science & Engineering, Inc. by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • PSTAortic Annuloplasty Ring2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K163608HAART 300 Aortic Annuloplasty Device 19mm, HAART 300 Aortic Annuloplasty Device 21mm, HAART 300 Aortic…Biostable Science & Engineering, Inc. · 20171cites it

What has FDA decided for it lately?

  • K171431HAART 200 Aortic Annuloplasty Device 19mm, HAART 200 Aortic Annuloplasty Device 21mm, HAART 200 Aortic…Biostable Science & Engineering, Inc. · 2017
  • K163608HAART 300 Aortic Annuloplasty Device 19mm, HAART 300 Aortic Annuloplasty Device 21mm, HAART 300 Aortic…Biostable Science & Engineering, Inc. · 2017

All 2 as Biostable Science & Engineering, Inc. →