FDA product code EAK: Screen, Leaded, Operator Radiation Protector
EAK is the FDA product code for screen, leaded, operator radiation protector. It is a Class I device, regulated under 21 CFR 892.6500 and reviewed by the Radiology panel. FDA has cleared 7 510(k) submissions under EAK, from 5 different applicants. The average 510(k) review took 66 days (median 41).
Classification
| Field | Value |
|---|---|
| Device name | Screen, Leaded, Operator Radiation Protector |
| Device class | Class I |
| Regulation | 21 CFR 892.6500 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every EAK clearance
Top EAK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Victoreen, Inc. | 3 | 1995-06-16 |
| Med Corp. | 1 | 1995-05-11 |
| Image Diagnostics, Inc. | 1 | 1994-10-20 |
| Innovative Products Mfg. | 1 | 1990-02-16 |
| Phase One Disign Co. | 1 | 1986-04-02 |
Most recent EAK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K952233 | Victoreen, Inc. | CLEAR-PB LEAD PLASTIC OVERHEAD BARRIER 56-628 | 1995-06-16 | 35 |
| K944445 | Med Corp. | ED CORP RADIATION SCREEN | 1995-05-11 | 241 |
| K944772 | Image Diagnostics, Inc. | MULTIPLE ED1600 SERIES RADIATION SHIELDS | 1994-10-20 | 23 |
| K896949 | Innovative Products Mfg. | MOBILE X-RAY PERSONNEL PROTECTIVE SCREENS | 1990-02-16 | 65 |
| K861019 | Phase One Disign Co. | CEILING MOUNT COUNTERPOISED SECON RADIATION SHIELD | 1986-04-02 | 15 |
Recalls for EAK devices
openFDA lists no recalls for product code EAK.
Frequently asked questions
What is FDA product code EAK?
EAK is the FDA product code for screen, leaded, operator radiation protector. It is a Class I device, regulated under 21 CFR 892.6500 and reviewed by the Radiology panel.
What device class is EAK?
Class I, regulation 21 CFR 892.6500. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EAK?
Across 7 cleared submissions the average was 66 days from receipt to decision (median 41).
Which companies have the most EAK clearances?
Victoreen, Inc. (3); Med Corp. (1); Image Diagnostics, Inc. (1); Innovative Products Mfg. (1); Phase One Disign Co. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code EAK
- Run a recall and safety report across every EAK manufacturer
- Watch product code EAK 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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