Product code SDT— Anesthesiology

RESPIRONICS SIMPLYCLEAR DEVICE

Classification name: Intra-Pulmonary Percussive Vibration (Ipv) Devices
Device class: Class 2
Regulation: 21 CFR 868.5665
Advisory panel: Anesthesiology
Total cleared: 3
First cleared: 2012-12-31
Most recent: 2024-12-23

FDA classification definition

“It is intended to mobilize mucus using vibration and/or pressure delivered through a mouthpiece into the airways.”
— U.S. Food and Drug Administration, device classification record for product code SDT under 21 CFR 868.5665, via openFDA

Market context for product code SDT

FDA has cleared 3 devices under product code SDT between 2012 and 2024, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

20241 clearance
20141 clearance
20121 clearance

Top applicants under product code SDT

Westmed, Inc.1 clearance
Respironics, Inc.1 clearance
Inogen, Inc.1 clearance

Recent clearances under product code SDT

K241091 — SIMEOX 200 Airway Clearance DeviceInogen, Inc.·2024-12-23
K133057 — VIBRALUNG ACOUSTICAL PERCUSSORWestmed, Inc.·2014-05-23
K122111 — RESPIRONICS SIMPLYCLEAR DEVICERespironics, Inc.·2012-12-31

Data sourced from openFDA. This site is unofficial and independent of the FDA.