FDA product code IFH: Solution, Zenker'S
IFH is the FDA product code for solution, zenker's. It is a Class I device, regulated under 21 CFR 864.4010 and reviewed by the Pathology panel. FDA has cleared 2 510(k) submissions under IFH, from 2 different applicants. The average 510(k) review took 19 days (median 19).
Classification
| Field | Value |
|---|---|
| Device name | Solution, Zenker'S |
| Device class | Class I |
| Regulation | 21 CFR 864.4010 |
| Review panel | PA — Pathology |
| Medical specialty | Pathology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every IFH clearance
Top IFH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| E K Ind., Inc. | 1 | 1984-08-03 |
| Volu Sol Medical Industries | 1 | 1982-08-05 |
Most recent IFH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K842732 | E K Ind., Inc. | ZENKERS SOLUTION | 1984-08-03 | 21 |
| K822127 | Volu Sol Medical Industries | VOLU-SOL ZENKERS FIXATIVE | 1982-08-05 | 17 |
Recalls for IFH devices
openFDA lists no recalls for product code IFH.
Frequently asked questions
What is FDA product code IFH?
IFH is the FDA product code for solution, zenker's. It is a Class I device, regulated under 21 CFR 864.4010 and reviewed by the Pathology panel.
What device class is IFH?
Class I, regulation 21 CFR 864.4010. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IFH?
Across 2 cleared submissions the average was 19 days from receipt to decision (median 19).
Which companies have the most IFH clearances?
E K Ind., Inc. (1); Volu Sol Medical Industries (1).
Next steps
- Run an FDA pathway report with predicate devices for product code IFH
- Run a recall and safety report across every IFH manufacturer
- Watch product code IFH 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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