FDA product code EAJ: Apron, Leaded
EAJ is the FDA product code for apron, leaded. It is a Class I device, regulated under 21 CFR 892.6500 and reviewed by the Radiology panel. FDA has cleared 6 510(k) submissions under EAJ, from 5 different applicants. The average 510(k) review took 45 days (median 52). FDA has posted 25 recalls for EAJ devices.
Classification
| Field | Value |
|---|---|
| Device name | Apron, Leaded |
| 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 EAJ clearance
Top EAJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| E.M. Adams | 2 | 1983-09-29 |
| Bt Medical Co., Inc. | 1 | 1993-06-02 |
| Rinn Dental Products | 1 | 1991-09-27 |
| X-Tech, Ltd. | 1 | 1987-02-19 |
| Orthopedic Systems, Inc. | 1 | 1987-01-21 |
Most recent EAJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K931269 | Bt Medical Co., Inc. | LEAD APRON | 1993-06-02 | 86 |
| K913621 | Rinn Dental Products | RINN PROTECTIVE X-RAY APRON AND PROTECTIVE COLLAR | 1991-09-27 | 45 |
| K870563 | X-Tech, Ltd. | X-RAY APRON | 1987-02-19 | 9 |
| K870103 | Orthopedic Systems, Inc. | LEAD APRON CADDY | 1987-01-21 | 12 |
| K832601 | E.M. Adams | LEADED X-RAY APRON | 1983-09-29 | 58 |
Recalls for EAJ devices
25 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2019-06-07.
| Year | Recalls |
|---|---|
| 2019 | 24 |
Frequently asked questions
What is FDA product code EAJ?
EAJ is the FDA product code for apron, leaded. It is a Class I device, regulated under 21 CFR 892.6500 and reviewed by the Radiology panel.
What device class is EAJ?
Class I, regulation 21 CFR 892.6500. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EAJ?
Across 6 cleared submissions the average was 45 days from receipt to decision (median 52).
Which companies have the most EAJ clearances?
E.M. Adams (2); Bt Medical Co., Inc. (1); Rinn Dental Products (1); X-Tech, Ltd. (1); Orthopedic Systems, Inc. (1).
Have EAJ devices been recalled?
Yes: 25 product recalls across 2 recall events; the most recent began 2019-06-07.
Next steps
- Run an FDA pathway report with predicate devices for product code EAJ
- Run a recall and safety report across every EAJ manufacturer
- Watch product code EAJ 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.
All Radiology product codes · FDA product code lookup · 510(k) database search · 510(k) review times