510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K832590Substantially Equivalent

Mouth-to-Mouth Shield Applicator

Mem, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K832590 is the FDA 510(k) clearance record for MOUTH-TO-MOUTH SHIELD APPLICATOR, a class II device, cleared for Mem, Inc. on under FDA product code LAE (High Pressure Liquid Chromatography, Codeine). FDA records list 2 510(k) clearances for Mem, Inc., from to . As of , FDA records show no recalls naming K832590.

Clearance record

Decision date
Received
(73 days to decision)
Product code
LAE High Pressure Liquid Chromatography, Codeine
Regulation
21 CFR 862.3270
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Mem, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code LAE

Trailing 12 months

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

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