510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K031551Substantially Equivalent

Northstar Lidocaine Iontophoretic Controller (Northstar Controller-D)

Vyteris, Inc., Fair Lawn NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K031551 is the FDA 510(k) clearance record for NORTHSTAR LIDOCAINE IONTOPHORETIC CONTROLLER (NORTHSTAR CONTROLLER-D), a class II device, cleared for Vyteris, Inc. on under FDA product code KTB (Device, Iontophoresis, Specific Uses). FDA records list one 510(k) clearance for Vyteris, Inc. As of , FDA records show no recalls naming K031551.

Clearance record

Decision date
Received
(93 days to decision)
Product code
KTB Device, Iontophoresis, Specific Uses
Regulation
21 CFR 890.5525
Device class
Class II
Review panel
Physical Medicine
Applicant
Vyteris, Inc. 13-01 Pollitt Dr., Fair Lawn NJ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KTB

Trailing 12 months

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

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