510(k) · Cleared

Cleared

Phoresor II, Model PM900

K974855510(k) TraditionalCleared Mar 27, 199888-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

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

Cleared on Mar 27, 1998 as substantially equivalent to K934335 (Iomed, Inc., 1994) after an 88-day review. Its family tree reaches back 1 generation to 1994. 6 later devices descend from it.

Decided: Mar 27, 1998
Review: 88 days
Class: Class II
Product code: KTB
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K934335 (1994). 6 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 1 generation backK934335 Phoresor II Auto, Model PM800 ModificationIomed, Inc. · 1994
This deviceK974855 Phoresor II, Model PM900Iomed, Inc. · 1998
Descendant · cites it directly · 1 of its ownK063465 Champion Iontophoretic Drug Delivery DeviceIomed, Inc. · 2007
Descendant · cites it directly · 1 of its ownK021222 Lad, Model Lad-01Norwood Abbey, Ltd. · 2003
Descendant · 2 generations on · 0 of its ownK072946 Hybresis Iontophoresis Drug Delivery SystemEmpi · 2007
Descendant · 2 generations on · 0 of its ownK040525 Sonoprep Ultrasonic Skin Permeation System and Topical Anesthetic…Sontra Medical, Inc. · 2004
Descendant · cites it directly · 0 of its ownK031551 Northstar Lidocaine Iontophoretic Controller (Northstar Controller-D)Vyteris, Inc. · 2003

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

1999high 2 (2003) · low 0 (2000)2026

Most influential descendants

Showing 5 of 6 · See all

K063465Champion Iontophoretic Drug Delivery DeviceIomed, Inc. · 2007 · cites it directly1descendant
K021222Lad, Model Lad-01Norwood Abbey, Ltd. · 2003 · cites it directly1descendant
K072946Hybresis Iontophoresis Drug Delivery SystemEmpi · 2007 · 2 generations on0descendants
K040525Sonoprep Ultrasonic Skin Permeation System and Topical Anesthetic Kit, Model D2000Sontra Medical, Inc. · 2004 · 2 generations on0descendants
K031551Northstar Lidocaine Iontophoretic Controller (Northstar Controller-D)Vyteris, Inc. · 2003 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K934335	Phoresor II Auto, Model PM800 Modification	Iomed, Inc.	1994	—
0 (this device)	K974855	Phoresor II, Model PM900	Iomed, Inc.	1998	—
+1	K063465	Champion Iontophoretic Drug Delivery Device	Iomed, Inc.	2007	—
+1	K021222	Lad, Model Lad-01	Norwood Abbey, Ltd.	2003	—
+2	K072946	Hybresis Iontophoresis Drug Delivery System	Empi	2007	—
+2	K040525	Sonoprep Ultrasonic Skin Permeation System and Topical Anesthetic Kit, Model…	Sontra Medical, Inc.	2004	—
+1	K031551	Northstar Lidocaine Iontophoretic Controller (Northstar Controller-D)	Vyteris, Inc.	2003	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0
2003	2	0
2004	1	0
2007	2	0

FIG. 1 — Lineage of K974855, 1994–2007Source: 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

Get a 510(k) Report

What was it cleared against? (1)

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
*	K934335	Phoresor II Auto, Model PM800 Modification Summary page 1 …stems Device Name: Iontophoresis Device Iontophoretic Device Modification Phoresor® II, Model PM900 Predicate Device: Iontophoresis Device Phoresor® II , Model PM800 K934335 Description of Device: An iontophoresis device is a device that is intended to use a direct current to introduce ions of solubl…	Iomed, Inc.	1994	—

Also cleared against K934335: 2 other devices →

What descends from it? (6)

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K063465	Champion Iontophoretic Drug Delivery Device	Iomed, Inc.	2007	1
K021222	Lad, Model Lad-01	Norwood Abbey, Ltd.	2003	1
K031551	Northstar Lidocaine Iontophoretic Controller (Northstar Controller-D)	Vyteris, Inc.	2003	0
K991991	Dupel Iontophoresis System	Empi	1999	0

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?

Its one ancestor has no recall.
Of its descendants, K063465 (Iomed, Inc., 2007) has gone furthest, with 1 descendant of its own.
2 other devices also cite its predicate K934335.

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?

The Iomed, Inc. Phoresor II PM900 is indicated for production of local dermal anesthesia using Iontocaine™ (brand of lidocaine hydrochloride 2% and epinephrine 1:100,000 Topical Solution).

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K974855 · printed Nov 6, 2026

Cite this page

510(k) Report. “K974855: Phoresor II, Model PM900.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974855

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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