510(k) Report

FDA applicant

Stethoscopes of America, Inc.

Stone Mountain, GA1 decision1992–19920 recalls

FDA records 1 decision for Stethoscopes of America, Inc. (Stone Mountain, GA) in 1992: 1 510(k) clearance. All are in product code LDE (Stethoscope, Manual). 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 Stethoscopes of America, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Stethoscopes of America, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Stethoscopes of America, Inc.’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