FDA product code PEQ: Accessories To Examination Light
PEQ is the FDA product code for accessories to examination light. It is a Class I device, regulated under 21 CFR 880.6320 and reviewed by the General Hospital panel. FDA has cleared 1 510(k) submission under PEQ. The average 510(k) review took 62 days (median 62).
Definition
Accessories that attach to the light and assist in magnifying, clarifying, enhancing the image being viewed.
Classification
| Field | Value |
|---|---|
| Device name | Accessories To Examination Light |
| Device class | Class I |
| Regulation | 21 CFR 880.6320 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every PEQ clearance
Top PEQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Globalmedia Group, LLC | 1 | 2013-07-10 |
Most recent PEQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K131338 | Globalmedia Group, LLC | DERMA HOOD | 2013-07-10 | 62 |
Recalls for PEQ devices
openFDA lists no recalls for product code PEQ.
Frequently asked questions
What is FDA product code PEQ?
PEQ is the FDA product code for accessories to examination light. It is a Class I device, regulated under 21 CFR 880.6320 and reviewed by the General Hospital panel.
What device class is PEQ?
Class I, regulation 21 CFR 880.6320. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code PEQ?
Across 1 cleared submissions the average was 62 days from receipt to decision (median 62).
Which companies have the most PEQ clearances?
Globalmedia Group, LLC (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PEQ
- Run a recall and safety report across every PEQ manufacturer
- Watch product code PEQ 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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