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
K904559Substantially Equivalent

Qualtex Skin Marker

Qualtex, Inc., Powell TN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K904559 is the FDA 510(k) clearance record for QUALTEX SKIN MARKER, a class I device, cleared for Qualtex, Inc. on under FDA product code FZZ (Marker, Skin). FDA records list 2 510(k) clearances for Qualtex, Inc., from to . As of , FDA records show no recalls naming K904559.

Clearance record

Decision date
Received
(69 days to decision)
Product code
FZZ Marker, Skin
Regulation
21 CFR 878.4660
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Qualtex, Inc. 200 Debusk Ln., Powell TN
Third party review
No

Clearances, product code FZZ

Trailing 12 months

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

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