Data / Medical devices / Transducer, Miniature Pressure
Transducer, Miniature Pressure (IKE): 10 FDA-registered makers in 4 countries
10 establishments in 4 countries are registered with the FDA to make Transducer, Miniature Pressure (product code IKE, Class 1, 21 CFR 890.1615). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 15 510(k) clearances under this code, the latest on March 16, 2006, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- IKE
- Device class
- 1
- Regulation
- 890.1615
- Medical specialty
- Physical Medicine
Makers by country
| Country | Makers |
|---|---|
| United States | 7 |
| Israel | 1 |
| United Kingdom | 1 |
| Germany | 1 |
Makers of Transducer, Miniature Pressure
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Avertto Medical Ltd. | Aderet Jerusalem, Israel | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aptyx - South Glens Falls | S Glens Falls, NY, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Controltek, Inc. | Vancouver, WA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CranioMandibular Rehab, Inc. | Wheat Ridge, CO, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Digitimer Ltd. | Welwyn Garden City Hertfordshire, United Kingdom | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Glottal Ent., Inc. | Syracuse, NY, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Iopi Medical LLC | Woodinville, WA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Novel GMBH | MUNICH Bavaria, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Progia Medical Inc. | Plymouth, MN, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Quality Tech Services, LLC | Bloomington, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated March 16, 2006. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.