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
K940133Substantially Equivalent

The Expandacell Ear Pack

Denver Splint Co., Englewood CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K940133 is the FDA 510(k) clearance record for THE EXPANDACELL EAR PACK, a class I device, cleared for Denver Splint Co. on under FDA product code LRD (Applicator, Ent Drug). FDA records list 4 510(k) clearances for Denver Splint Co., from to . As of , FDA records show no recalls naming K940133.

Clearance record

Decision date
Received
(140 days to decision)
Product code
LRD Applicator, Ent Drug
Regulation
21 CFR 874.5220
Device class
Class I
Review panel
Ear, Nose, Throat
Applicant
Denver Splint Co. 7002 S. Revere Pkwy., Englewood CO
510(k) summary
Summary
Third party review
No

Clearances, product code LRD

Trailing 12 months

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

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