FDA product code IKE: Transducer, Miniature Pressure
IKE is the FDA product code for transducer, miniature pressure. It is a Class I device, regulated under 21 CFR 890.1615 and reviewed by the Physical Medicine panel. FDA has cleared 15 510(k) submissions under IKE, from 14 different applicants. The average 510(k) review took 106 days (median 57).
Classification
| Field | Value |
|---|---|
| Device name | Transducer, Miniature Pressure |
| Device class | Class I |
| Regulation | 21 CFR 890.1615 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every IKE clearance
Top IKE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Broadwest Corp. | 2 | 1987-02-04 |
| Palpometer Systems, Inc. | 1 | 2006-03-16 |
| Cleveland Medical Devices, Inc. | 1 | 1995-10-30 |
| Advanced Rehabilitative Technology, Inc. | 1 | 1993-03-22 |
| Bar Med Pty , Ltd. | 1 | 1992-10-20 |
9 more applicants have IKE clearances. See the full list in Caduvo.
Most recent IKE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K060125 | Palpometer Systems, Inc. | SONIC PALPOMETER | 2006-03-16 | 57 |
| K954670 | Cleveland Medical Devices, Inc. | PRESSORE MONITOR | 1995-10-30 | 20 |
| K915369 | Advanced Rehabilitative Technology, Inc. | THE EQUALIZER | 1993-03-22 | 481 |
| K915326 | Bar Med Pty , Ltd. | PORTABLE LIMB LOAD MONITOR (BMLLM-100) | 1992-10-20 | 333 |
| K920091 | Breakthrough, Inc. | IOWA ORAL PERFORMANCE ISNTRUMENT | 1992-05-20 | 133 |
Recalls for IKE devices
openFDA lists no recalls for product code IKE.
Frequently asked questions
What is FDA product code IKE?
IKE is the FDA product code for transducer, miniature pressure. It is a Class I device, regulated under 21 CFR 890.1615 and reviewed by the Physical Medicine panel.
What device class is IKE?
Class I, regulation 21 CFR 890.1615. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IKE?
Across 15 cleared submissions the average was 106 days from receipt to decision (median 57).
Which companies have the most IKE clearances?
Broadwest Corp. (2); Palpometer Systems, Inc. (1); Cleveland Medical Devices, Inc. (1); Advanced Rehabilitative Technology, Inc. (1); Bar Med Pty , Ltd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code IKE
- Run a recall and safety report across every IKE manufacturer
- Watch product code IKE 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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