SDSClass II

Compression-Based Airway Clearance Device

21 CFR 868.5665 / Anesthesiology

SDS is the FDA product code for Compression-Based Airway Clearance Device, a class II device type, regulated under 21 CFR 868.5665. FDA's definition for this code reads: "It is intended to support bronchial drainage breathing techniques by providing oscillating regional compression to the thorax". As of 2026-09-10, FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code: SDS
Device name: Compression-Based Airway Clearance Device
FDA definition: It is intended to support bronchial drainage breathing techniques by providing oscillating regional compression to the thorax.
Regulation: 21 CFR 868.5665
Device class: Class II
Review panel: Anesthesiology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 0
Ingested recalls: 0

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code SDS.

Recent clearances

Product code SDS

FDA records hold no clearances under product code SDS.

Recent recalls

Product code SDS

FDA records show no recalls under product code SDS.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)