# K031551: Northstar Lidocaine Iontophoretic Controller (Northstar Controller-D)

- Pathway: 510(k) (Traditional)
- Applicant: Vyteris, Inc.
- Decided: Aug 20, 2003 after 93 days
- Product code: KTB (Device, Iontophoresis, Specific Uses)
- Device class: 2
- Regulation: 21 CFR 890.5525
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K934335 (1994). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974855: Phoresor II, Model PM900, Iomed, Inc. (1998) Summary page 1.
- K982668: Phoresor II,Model PM900, Iomed, Inc. (1999) Summary page 1.

## Indications for use
Northstar System is indicated for the administration of lidocaine hydrochloride to provide local dermal anesthesia on normal intact skin. This system is an alternative to hypodermic injection or topical application of lidocaine hydrochloride. Northstar System is indicated for use on patients 5 years of age and older.

Source page: https://510kreport.com/device/K031551
Methodology: https://510kreport.com/methodology