FDA product code FOK: Pad, Neonatal Eye
FOK is the FDA product code for pad, neonatal eye. It is a Class I device, regulated under 21 CFR 880.5270 and reviewed by the General Hospital panel. FDA has cleared 5 510(k) submissions under FOK, from 5 different applicants. The average 510(k) review took 42 days (median 30).
Classification
| Field | Value |
|---|---|
| Device name | Pad, Neonatal Eye |
| Device class | Class I |
| Regulation | 21 CFR 880.5270 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every FOK clearance
Top FOK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Debusk Technology Corp. | 1 | 1996-07-03 |
| Graphic Controls Corp. | 1 | 1993-03-15 |
| Alba Health Care | 1 | 1985-06-07 |
| A & A Medical Supplies Co. | 1 | 1984-03-23 |
| Montrose Phototherapy Supply | 1 | 1981-12-09 |
Most recent FOK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K962290 | Debusk Technology Corp. | DEROYAL INDUSTRIES, INC. NEONATAL EYE COVER | 1996-07-03 | 19 |
| K926118 | Graphic Controls Corp. | LIFE TRACE(R) BILIRUBIN MASK | 1993-03-15 | 102 |
| K851918 | Alba Health Care | INFANT PHOTOTHERAPY MASK | 1985-06-07 | 36 |
| K840894 | A & A Medical Supplies Co. | PHOTO-THERAPY EYE PROTECTOR | 1984-03-23 | 25 |
| K813214 | Montrose Phototherapy Supply | INFANT PHOTOTHERAPY MASK | 1981-12-09 | 30 |
Recalls for FOK devices
openFDA lists no recalls for product code FOK.
Frequently asked questions
What is FDA product code FOK?
FOK is the FDA product code for pad, neonatal eye. It is a Class I device, regulated under 21 CFR 880.5270 and reviewed by the General Hospital panel.
What device class is FOK?
Class I, regulation 21 CFR 880.5270. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FOK?
Across 5 cleared submissions the average was 42 days from receipt to decision (median 30).
Which companies have the most FOK clearances?
Debusk Technology Corp. (1); Graphic Controls Corp. (1); Alba Health Care (1); A & A Medical Supplies Co. (1); Montrose Phototherapy Supply (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FOK
- Run a recall and safety report across every FOK manufacturer
- Watch product code FOK 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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