FDA product code KTB: Device, Iontophoresis, Specific Uses
KTB is the FDA product code for device, iontophoresis, specific uses. It is a Class II device, regulated under 21 CFR 890.5525 and reviewed by the Physical Medicine panel. FDA has cleared 16 510(k) submissions under KTB, from 8 different applicants. The average 510(k) review took 90 days (median 86).
Classification
| Field | Value |
|---|---|
| Device name | Device, Iontophoresis, Specific Uses |
| Device class | Class II |
| Regulation | 21 CFR 890.5525 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for KTB
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 140 |
Compare with all 510(k) review times · Search every KTB clearance
Top KTB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Iomed, Inc. | 6 | 2003-12-22 |
| Wescor, Inc. | 3 | 2001-03-20 |
| Medtronic Vascular | 2 | 1990-04-23 |
| Elitechgroup, Inc. | 1 | 2018-07-27 |
| Vyteris, Inc. | 1 | 2003-08-20 |
3 more applicants have KTB clearances. See the full list in Caduvo.
Most recent KTB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K180627 | Elitechgroup, Inc. | Macroduct Advanced Model 3710 | 2018-07-27 | 140 |
| K033192 | Iomed, Inc. | RH-950 | 2003-12-22 | 81 |
| K031551 | Vyteris, Inc. | NORTHSTAR LIDOCAINE IONTOPHORETIC CONTROLLER (NORTHSTAR CONTROLLER-D) | 2003-08-20 | 93 |
| K031115 | Iomed, Inc. | RH-900 | 2003-07-10 | 93 |
| K010031 | Wescor, Inc. | NANODUCT NEONATAL SWEAT ANALYSIS SYSTEM | 2001-03-20 | 76 |
Recalls for KTB devices
openFDA lists no recalls for product code KTB.
Frequently asked questions
What is FDA product code KTB?
KTB is the FDA product code for device, iontophoresis, specific uses. It is a Class II device, regulated under 21 CFR 890.5525 and reviewed by the Physical Medicine panel.
What device class is KTB?
Class II, regulation 21 CFR 890.5525. Typical premarket route: 510(k).
How long does a 510(k) take for product code KTB?
Across 16 cleared submissions the average was 90 days from receipt to decision (median 86).
Which companies have the most KTB clearances?
Iomed, Inc. (6); Wescor, Inc. (3); Medtronic Vascular (2); Elitechgroup, Inc. (1); Vyteris, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KTB
- Run a recall and safety report across every KTB manufacturer
- Watch product code KTB for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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