510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
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K960593Substantially Equivalent

Smartmist Asthma Managment System, Smartmist, Model Number Sm-100/Smartmist Spirometry Airway, Model Number Sa-100

Aradigm Corp., Hayward CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K960593 is the FDA 510(k) clearance record for SMARTMIST ASTHMA MANAGMENT SYSTEM, SMARTMIST, MODEL NUMBER SM-100/SMARTMIST SPIROMETRY AIRWAY, MODEL NUMBER SA-100, a class I device, cleared for Aradigm Corp. on under FDA product code CCQ (Nebulizer, Medicinal, Non-Ventilatory (Atomizer)). FDA records list one 510(k) clearance for Aradigm Corp. As of , FDA records show no recalls naming K960593.

Clearance record

Decision date
Received
(88 days to decision)
Product code
CCQ Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
Regulation
21 CFR 868.5640
Device class
Class I
Review panel
Anesthesiology
Applicant
Aradigm Corp. 26219 Eden Landing Rd., Hayward CA
510(k) summary
Summary
Third party review
No

Clearances, product code CCQ

Trailing 12 months

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

FDA records show no clearances under product code CCQ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code CCQ, 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