FDA product code · Anesthesiology

Compression-Based Airway Clearance Device

Name: FDA decisions, review times, recalls and adverse event reports for product code SDS
Creator: 510(k) Report

SDSClass II21 CFR 868.5665510(k) required0 decisions0 recalls

0 FDA decisions. No recall names this code.

It is intended to support bronchial drainage breathing techniques by providing oscillating regional compression to the thorax.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, anesthesiology panel

Twenty years of SDS at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

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

Planning a device in SDS? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

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