510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K811684Substantially Equivalent

American Aircare System

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

K811684 is the FDA 510(k) clearance record for AMERICAN AIRCARE SYSTEM, a class II device, cleared for American Hamilton on under FDA product code FNM (Mattress, Air Flotation, Alternating Pressure). FDA records list 3 510(k) clearances for American Hamilton, from to . As of , FDA records show no recalls naming K811684.

Clearance record

Decision date
Received
(17 days to decision)
Product code
FNM Mattress, Air Flotation, Alternating Pressure
Regulation
21 CFR 880.5550
Device class
Class II
Review panel
General Hospital
Applicant
American Hamilton 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code FNM

Trailing 12 months

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

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