510(k) · Cleared
ClearedRH-950
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 Dec 22, 2003 as substantially equivalent to K031115 (Iomed, Inc., 2003) after an 81-day review. Its family tree reaches back 4 generations to 1991. 3 later devices descend from it.
- Decided
- Dec 22, 2003
- Review
- 81 days
- Class
- Class II
- Product code
- KTB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K912015 (1991). 7 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK912015 TBD, Empi Buffered Iontophoresis Electroded MDL. 3Empi · 1991
- 3 generations backK970491 Dupel II Buffered Iontophoresis ElectrodesEmpi · 1997
- 2 generations backK983484 Dupel B.L.U.E. Small Iontophoresis ElectrodeEmpi · 1998
- 1 generation backK031115 RH-900Iomed, Inc. · 2003
- This deviceK033192 RH-950Iomed, Inc. · 2003
- Descendant · cites it directly · 1 of its ownK063465 Champion Iontophoretic Drug Delivery DeviceIomed, Inc. · 2007
- Descendant · cites it directly · 0 of its ownK132832 Activapatch ET Iontophoresis PatchActivatek, Inc. · 2014
- Descendant · 2 generations on · 0 of its ownK072946 Hybresis Iontophoresis Drug Delivery SystemEmpi · 2007
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K912015 | TBD, Empi Buffered Iontophoresis Electroded MDL. 3 | Empi | 1991 | — |
| −3 | K970491 | Dupel II Buffered Iontophoresis Electrodes | Empi | 1997 | — |
| −2 | K983484 | Dupel B.L.U.E. Small Iontophoresis Electrode | Empi | 1998 | — |
| −1 | K031115 | RH-900 | Iomed, Inc. | 2003 | — |
| 0 (this device) | K033192 | RH-950 | Iomed, Inc. | 2003 | — |
| +1 | K063465 | Champion Iontophoretic Drug Delivery Device | Iomed, Inc. | 2007 | — |
| +1 | K132832 | Activapatch ET Iontophoresis Patch | Activatek, Inc. | 2014 | — |
| +2 | K072946 | Hybresis Iontophoresis Drug Delivery System | Empi | 2007 | — |
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 |
|---|---|---|
| 2007 | 2 | 0 |
| 2014 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K031115 | RH-900Summary page 1….5525 Proprietary Name: RH-950 Common Name: lontophoresis Drug Delivery Electrode B. Name of Predicate Devicejs) · lontophoresis Device: K031115 lontophoresis Drug Delivery Electrode !OMED, Inc. RH-900 * lontophoresis Device: K990318 lontophoresis Drug… | 2003 |
| Kept off the family tree | K990318 | Birch Point IontoPatch Iontophoresis Drug Delivery Electrode Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1…ctrode B. Name of Predicate Devicejs) · lontophoresis Device: K031115 lontophoresis Drug Delivery Electrode !OMED, Inc. RH-900 * lontophoresis Device: K990318 lontophoresis Drug Delivery Electrode Birch Point lontoPatch C. Device Description An iontophoresis device is i… |
What descends from it? (3)
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 7 ancestors has a recall.
- Of its descendants, K063465 (Iomed, Inc., 2007) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K031115.
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/K033192 · printed Nov 3, 2026
Cite this page
510(k) Report. “K033192: RH-950.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033192
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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