510(k) · Cleared
ClearedRH-900
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Iomed, Inc. · KTB Device, Iontophoresis, Specific Uses
Cleared on Jul 10, 2003 as substantially equivalent to K932620 (Iomed, Inc., 1994) and 1 other predicate after a 93-day review. Its family tree reaches back 3 generations to 1991. 6 later devices descend from it.
- Decided
- Jul 10, 2003
- Review
- 93 days
- Class
- Class II
- Product code
- KTB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K912015 (1991). 6 ancestors in all. 6 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK912015 TBD, Empi Buffered Iontophoresis Electroded MDL. 3Empi · 1991
- 2 generations backK970491 Dupel II Buffered Iontophoresis ElectrodesEmpi · 1997
- 1 generation backK983484 Dupel B.L.U.E. Small Iontophoresis ElectrodeEmpi · 1998
- This deviceK031115 RH-900Iomed, Inc. · 2003
- Descendant · cites it directly · 3 of its ownK033192 RH-950Iomed, Inc. · 2003
- Descendant · 2 generations on · 1 of its ownK063465 Champion Iontophoretic Drug Delivery DeviceIomed, Inc. · 2007
- Descendant · cites it directly · 1 of its ownK043047 Dynatron Ibox Iontophoresis DeviceDynatronics Corp. · 2005
- Descendant · 2 generations on · 0 of its ownK170291 IontoDCSoterix Medical, Inc. · 2017
- Descendant · 2 generations on · 0 of its ownK132832 Activapatch ET Iontophoresis PatchActivatek, Inc. · 2014
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K033192RH-950Iomed, Inc. · 2003 · cites it directly3descendants
- K063465Champion Iontophoretic Drug Delivery DeviceIomed, Inc. · 2007 · 2 generations on1descendant
- K043047Dynatron Ibox Iontophoresis DeviceDynatronics Corp. · 2005 · cites it directly1descendant
- K170291IontoDCSoterix Medical, Inc. · 2017 · 2 generations on0descendants
- K132832Activapatch ET Iontophoresis PatchActivatek, Inc. · 2014 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K912015 | TBD, Empi Buffered Iontophoresis Electroded MDL. 3 | Empi | 1991 | — |
| −2 | K970491 | Dupel II Buffered Iontophoresis Electrodes | Empi | 1997 | — |
| −1 | K983484 | Dupel B.L.U.E. Small Iontophoresis Electrode | Empi | 1998 | — |
| 0 (this device) | K031115 | RH-900 | Iomed, Inc. | 2003 | — |
| +1 | K033192 | RH-950 | Iomed, Inc. | 2003 | — |
| +2 | K063465 | Champion Iontophoretic Drug Delivery Device | Iomed, Inc. | 2007 | — |
| +1 | K043047 | Dynatron Ibox Iontophoresis Device | Dynatronics Corp. | 2005 | — |
| +2 | K170291 | IontoDC | Soterix Medical, Inc. | 2017 | — |
| +2 | K132832 | Activapatch ET Iontophoresis Patch | Activatek, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1994 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 2 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K932620 | RH-806/GS Model Transq (R)2Summary page 1….5525 Proprietary Name: RH-900 Common Name: Iontophoresis Drug Delivery Electrode 13. Name of Predicate Device(s1 Iontophoresis Device K932620 Iontophoresis Drug Delivery Electrode Ionied, Inc. RH-806/GS (TransQ*/GS) Iontophoresis Device K983484… | 1994 |
| * | K983484 | Dupel B.L.U.E. Small Iontophoresis ElectrodeSummary page 1…edicate Device(s1 Iontophoresis Device K932620 Iontophoresis Drug Delivery Electrode Ionied, Inc. RH-806/GS (TransQ*/GS) Iontophoresis Device K983484 Iontophoresis Drug Delivery Electrode Empi Dupe1 B.L.U.E.Thl(Bi-layer Ultra Electrode) C. Device Description… | 1998 |
What descends from it? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 12 years and passes through 2 companies; a new generation was cleared every 4.5 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K033192 (Iomed, Inc., 2003) has gone furthest, with 3 descendants of its own.
- 5 other devices also cite its predicate K932620.
How does its category compare?
All KTB devicesKTB Device, Iontophoresis, Specific Uses: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KTB
1in 2018
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
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 | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 4 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 2 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Iontophoretic drug delivery electrodes are indicated for the administration of soluble salts or other drugs into the body for medical purposes as an alternative to hypodermic injections. They are also indicated for iontophoretic dermal administration of IONTOCAINE® (Lidocaine HCl 2% and Epinephrine 1:100,000 Topical Solution).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031115 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031115: RH-900.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031115
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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