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SDTClass II

Intra-Pulmonary Percussive Vibration (Ipv) Devices

21 CFR 868.5665 / Anesthesiology
FDA source (opens on fda.gov)

SDT is the FDA product code for Intra-Pulmonary Percussive Vibration (Ipv) Devices, a class II device type, regulated under 21 CFR 868.5665. FDA's definition for this code reads: "It is intended to mobilize mucus using vibration and/or pressure delivered through a mouthpiece into the airways". As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
SDT
Device name
Intra-Pulmonary Percussive Vibration (Ipv) Devices
FDA definition
It is intended to mobilize mucus using vibration and/or pressure delivered through a mouthpiece into the airways.
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
3
Ingested recalls
0

Clearances, product code SDT

By decision year
3 clearances under product code SDT with a decision year between 2012 and 2024, 2012 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code SDT by decision year
YearClearances
20121
20141
20241

Applicants with the most clearances

Product code SDT
Applicants holding the most 510(k) clearances under product code SDT
ApplicantClearances
Inogen, Inc1
Respironics, Inc.1
Westmed Inc1

Companies listing this code with FDA

Companies whose registered establishments list this code