510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K031686Substantially Equivalent

Aeromist Lt, Model Hcs15004

MEDLINE INDUSTRIES, LP - Northfield, Mundelein IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K031686 is the FDA 510(k) clearance record for AEROMIST LT, MODEL HCS15004, a class II device, cleared for Medline Industries, Inc. on under FDA product code BTI (Compressor, Air, Portable). FDA records list 414 510(k) clearances for MEDLINE INDUSTRIES, LP - Northfield, from to . As of , FDA records show no recalls naming K031686.

Clearance record

Decision date
Received
(233 days to decision)
Product code
BTI Compressor, Air, Portable
Regulation
21 CFR 868.6250
Device class
Class II
Review panel
Anesthesiology
Applicant
Medline Industries, Inc. One Medline Pl., Mundelein IL
510(k) summary
Statement
Third party review
No

Clearances, product code BTI

Trailing 12 months

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

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