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
K831603Substantially Equivalent

Titan Ge/ieplate

Helena Laboratories, Corp., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K831603 is the FDA 510(k) clearance record for TITAN GE/IEPLATE, a class I device, cleared for Helena Laboratories on under FDA product code JZR (Support Gels). FDA records list 282 510(k) clearances for Helena Laboratories, from to . As of , FDA records show no recalls naming K831603.

Clearance record

Decision date
Received
(50 days to decision)
Product code
JZR Support Gels
Regulation
21 CFR 866.4900
Device class
Class I
Review panel
Immunology
Applicant
Helena Laboratories 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code JZR

Trailing 12 months

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

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