FDA product code JEJ: Tubing, Instrumentation, Bronchoscope (Brush Sheath A/O Aspirating)
JEJ is the FDA product code for tubing, instrumentation, bronchoscope (brush sheath a/o aspirating). It is a Class II device, regulated under 21 CFR 874.4680 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 2 510(k) submissions under JEJ, from 2 different applicants. The average 510(k) review took 16 days (median 16).
Definition
If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Classification
| Field | Value |
|---|---|
| Device name | Tubing, Instrumentation, Bronchoscope (Brush Sheath A/O Aspirating) |
| Device class | Class II |
| Regulation | 21 CFR 874.4680 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every JEJ clearance
Top JEJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Em Diagnostic Systems, Inc. | 1 | 1987-12-22 |
| Technicon Instruments Corp. | 1 | 1982-05-10 |
Most recent JEJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K874705 | Em Diagnostic Systems, Inc. | EASY-TEST AMYLASE (AMYL), ITEM NUMBER 19019 | 1987-12-22 | 33 |
| K821514 | Technicon Instruments Corp. | TECHNICON RA-1000 SYS, ANALYTES III | 1982-05-10 | 0 |
Recalls for JEJ devices
openFDA lists no recalls for product code JEJ.
Frequently asked questions
What is FDA product code JEJ?
JEJ is the FDA product code for tubing, instrumentation, bronchoscope (brush sheath a/o aspirating). It is a Class II device, regulated under 21 CFR 874.4680 and reviewed by the Ear, Nose and Throat panel.
What device class is JEJ?
Class II, regulation 21 CFR 874.4680. Typical premarket route: 510(k).
How long does a 510(k) take for product code JEJ?
Across 2 cleared submissions the average was 16 days from receipt to decision (median 16).
Which companies have the most JEJ clearances?
Em Diagnostic Systems, Inc. (1); Technicon Instruments Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JEJ
- Run a recall and safety report across every JEJ manufacturer
- Watch product code JEJ 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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