FDA applicant

Diacoustic Medical Devices (Pty), Ltd.

Crofton, MD2 decisions2011–20130 recalls

FDA records 2 decisions for Diacoustic Medical Devices (Pty), Ltd. (Crofton, MD) from 2011 to 2013: 2 510(k) clearances. All are in product code DQD (Stethoscope, Electronic). Its devices cite 3 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 Diacoustic Medical Devices (Pty), Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2011high 1 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Diacoustic Medical Devices (Pty), Ltd. by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

See the 510(k) Report

Other applicant names beginning “Diacoustic”

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

Diacoustic Medical (Pty) 1

Diacoustic Medical Devices (Pty), Ltd.

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 “Diacoustic”