510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K850926Substantially Equivalent

Micron One Porta. Ultrasonic Nebulizer

Endotek Development Laboratories, Salt Lake City UT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K850926 is the FDA 510(k) clearance record for MICRON ONE PORTA. ULTRASONIC NEBULIZER, a class I device, cleared for Endotek Development Laboratories on under FDA product code CCQ (Nebulizer, Medicinal, Non-Ventilatory (Atomizer)). FDA records list one 510(k) clearance for Endotek Development Laboratories. As of , FDA records show no recalls naming K850926.

Clearance record

Decision date
Received
(79 days to decision)
Product code
CCQ Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
Regulation
21 CFR 868.5640
Device class
Class I
Review panel
Anesthesiology
Applicant
Endotek Development Laboratories 417 Wakara Way, Salt Lake City UT
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