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
K894683Substantially Equivalent

Fabfoam #302

Jewell Industries, Bernalillo NM / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K894683 is the FDA 510(k) clearance record for FABFOAM #302, a class II device, cleared for Jewell Industries on under FDA product code JAD (System, Therapeutic, X-Ray). FDA records list one 510(k) clearance for Jewell Industries. As of , FDA records show no recalls naming K894683.

Clearance record

Decision date
Received
(44 days to decision)
Product code
JAD System, Therapeutic, X-Ray
Regulation
21 CFR 892.5900
Device class
Class II
Review panel
Radiology
Applicant
Jewell Industries P.O. Box 5580, Bernalillo NM
Third party review
No

Clearances, product code JAD

Trailing 12 months
1 clearance under product code JAD in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code JAD, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260