510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K833964Substantially Equivalent

Pegasus Mattress

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

K833964 is the FDA 510(k) clearance record for PEGASUS MATTRESS, a class II device, cleared for Dermalex Co. on under FDA product code FNM (Mattress, Air Flotation, Alternating Pressure). FDA records list one 510(k) clearance for Dermalex Co. As of , FDA records show no recalls naming K833964.

Clearance record

Decision date
Received
(75 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
Dermalex Co. 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