510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K842644Substantially Equivalent

Tpn/hyperalimentation Tray

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

K842644 is the FDA 510(k) clearance record for TPN/HYPERALIMENTATION TRAY, a class II device, cleared for Deroyal Industries, Inc. on under FDA product code FRG (Wrap, Sterilization). FDA records list 92 510(k) clearances for Deroyal Industries, Inc., from to . As of , FDA records show no recalls naming K842644.

Clearance record

Decision date
Received
(121 days to decision)
Product code
FRG Wrap, Sterilization
Regulation
21 CFR 880.6850
Device class
Class II
Review panel
General Hospital
Applicant
Deroyal Industries, Inc. 200 Debusk Ln., Powell TN
Third party review
No

Clearances, product code FRG

Trailing 12 months
5 clearances under product code FRG in the twelve months to October 2026, May 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code FRG, trailing twelve months
MonthClearances
November 20250
December 20251
January 20261
February 20260
March 20260
April 20260
May 20262
June 20260
July 20261
August 20260
September 20260
October 20260