510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K122111Substantially Equivalent

Respironics Simplyclear Device

Respironics, Inc., Murrysville PA / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K122111 is the FDA 510(k) clearance record for RESPIRONICS SIMPLYCLEAR DEVICE, a class II device, cleared for Respironics, Inc. on under FDA product code SDT (Intra-Pulmonary Percussive Vibration (Ipv) Devices). FDA's definition for product code SDT reads: "It is intended to mobilize mucus using vibration and/or pressure delivered through a mouthpiece into the airways". FDA records list 186 510(k) clearances for Respironics, Inc., from to . As of , FDA records show no recalls naming K122111.

Clearance record

Decision date
Received
(167 days to decision)
Product code
SDT Intra-Pulmonary Percussive Vibration (Ipv) Devices
Regulation
21 CFR 868.5665
Device class
Class II
Review panel
Anesthesiology
Applicant
Respironics, Inc. 1740 Golden Mile Hwy., Murrysville PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code SDT

Trailing 12 months

FDA records hold no clearances under product code SDT in the trailing twelve months.

FDA records show no clearances under product code SDT in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code SDT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260