FDA applicant

Jostra Bentley

Austin, TX3 decisions1995–19990 recalls

FDA records 3 decisions for Jostra Bentley (Austin, TX) from 1995 to 1999: 3 510(k) clearances. Most are in product codes DWC (Controller, Temperature, Cardiopulmonary Bypass) and DTZ (Oxygenator, Cardiopulmonary Bypass). Its devices cite 2 predicates, 0 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 Jostra Bentley’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Jostra Bentley since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Jostra Bentley by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Jostra Bentley’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Jostra”

FDA records each applicant name separately; these may or may not be the same firm.

Jostra AG 14 Jostra Medizintechnik AG 2

Jostra Bentley

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Jostra”