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
K803239Substantially Equivalent

Softgood Products and Splints

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

K803239 is the FDA 510(k) clearance record for SOFTGOOD PRODUCTS AND SPLINTS, a class I device, cleared for Danek Medical, Inc. on under FDA product code IPX (Orthosis, Rib Fracture, Soft). FDA records list 56 510(k) clearances for Danek Medical, Inc., from to . As of , FDA records show no recalls naming K803239.

Clearance record

Decision date
Received
(17 days to decision)
Product code
IPX Orthosis, Rib Fracture, Soft
Regulation
21 CFR 890.3490
Device class
Class I
Review panel
Physical Medicine
Applicant
Danek Medical, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code IPX

Trailing 12 months

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

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