510(k) · Cleared

Cleared

Northstar Lidocaine Iontophoretic Controller (Northstar Controller-D)

K031551510(k) TraditionalCleared Aug 20, 200393-day reviewClass II21 CFR 890.5525

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Vyteris, Inc. · KTB Device, Iontophoresis, Specific Uses

Cleared on Aug 20, 2003 as substantially equivalent to K974855 (Iomed, Inc., 1998) and 1 other predicate after a 93-day review. Its family tree reaches back 2 generations to 1994.

Decided: Aug 20, 2003
Review: 93 days
Class: Class II
Product code: KTB
Recalls: None
Predicates: 2

Its longest line of descent runs back 2 generations to K934335 (1994). 3 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK934335 Phoresor II Auto, Model PM800 ModificationIomed, Inc. · 1994
1 generation backK974855 Phoresor II, Model PM900Iomed, Inc. · 1998
This deviceK031551 Northstar Lidocaine Iontophoretic Controller (Northstar Controller-D)Vyteris, Inc. · 2003

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K934335	Phoresor II Auto, Model PM800 Modification	Iomed, Inc.	1994	—
−1	K974855	Phoresor II, Model PM900	Iomed, Inc.	1998	—
0 (this device)	K031551	Northstar Lidocaine Iontophoretic Controller (Northstar Controller-D)	Vyteris, Inc.	2003	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0

FIG. 1 — Lineage of K031551, 1994–2003Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in KTB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K974855	Phoresor II, Model PM900 Summary page 1 …d 21CFR890.5525 paragraph a (revised April 1,2002) 5.4 Predicate Device: Iontophoresis Device PhoresorB 11, Model PM900 K974855 & K982668 Manufactured by: IOMED, Inc. 3385 West 1820 South Salt Lake City, U…	Iomed, Inc.	1998	—
*	K982668	Phoresor II,Model PM900 Summary page 1 ….5525 paragraph a (revised April 1,2002) 5.4 Predicate Device: Iontophoresis Device PhoresorB 11, Model PM900 K974855 & K982668 Manufactured by: IOMED, Inc. 3385 West 1820 South Salt Lake City, UT 84104…	Iomed, Inc.	1999	—

Also cleared against K974855: 3 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 5.4 years on median.
None of the 3 ancestors has a recall.
3 other devices also cite its predicate K974855.

How does its category compare?

All KTB devices

KTB Device, Iontophoresis, Specific Uses: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KTB

1in 2018

2007high 1 (2018) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KTB

Too few KTB 510(k)s in any year since 2007 to give a median.

Recalls per year · KTB

No recall names KTB since 2007.

Adverse event reports per year · KTB

1in 2012

2007high 4 (2007) · low 0 (2013)2025

MAUDE reports naming product code KTB, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	4
2008	0	—	1
2009	0	—	2
2010	0	—	1
2011	0	—	1
2012	0	—	1
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	0
2018	1	—	0
2019	0	—	0
2020	0	—	0
2021	0	—	0
2022	0	—	0
2023	0	—	0
2024	0	—	0
2025	0	—	0
2026	0	—	—

What is it indicated for?

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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K031551 · printed Nov 6, 2026

Cite this page

510(k) Report. “K031551: Northstar Lidocaine Iontophoretic Controller (Northstar Controller-D).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031551

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026