FDA product code FHS: Dialyzer, Single Coil
FHS is the FDA product code for dialyzer, single coil. It is a Class II device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 12 510(k) submissions under FHS, from 5 different applicants. The average 510(k) review took 57 days (median 55).
Classification
| Field | Value |
|---|---|
| Device name | Dialyzer, Single Coil |
| Device class | Class II |
| Regulation | 21 CFR 876.5820 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Life-sustaining or supporting | Yes |
Compare with all 510(k) review times · Search every FHS clearance
Top FHS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Erika, Inc. | 6 | 1981-12-03 |
| Gambro, Inc. | 2 | 1980-02-13 |
| Travenol Laboratories, S.A. | 2 | 1979-03-26 |
| Bellco Artifidial Organ Spec., Inc. | 1 | 1980-12-17 |
| Bentley Laboratories, Inc. | 1 | 1977-01-10 |
Most recent FHS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K812811 | Erika, Inc. | MICROCOIL 80 DIALYZER | 1981-12-03 | 58 |
| K811974 | Erika, Inc. | MICROCOIL 150 DIALYZER | 1981-09-16 | 65 |
| K801634 | Bellco Artifidial Organ Spec., Inc. | THE VITA 2 DISPOSABLE DIALYZER | 1980-12-17 | 155 |
| K800723 | Erika, Inc. | MICRO-COIL 100 COIL DIALYZER | 1980-05-14 | 43 |
| K800174 | Gambro, Inc. | GAMBRO LUNDIA COIL DIALYZER | 1980-02-13 | 19 |
Recalls for FHS devices
openFDA lists no recalls for product code FHS.
Frequently asked questions
What is FDA product code FHS?
FHS is the FDA product code for dialyzer, single coil. It is a Class II device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel.
What device class is FHS?
Class II, regulation 21 CFR 876.5820. Typical premarket route: 510(k).
How long does a 510(k) take for product code FHS?
Across 12 cleared submissions the average was 57 days from receipt to decision (median 55).
Which companies have the most FHS clearances?
Erika, Inc. (6); Gambro, Inc. (2); Travenol Laboratories, S.A. (2); Bellco Artifidial Organ Spec., Inc. (1); Bentley Laboratories, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FHS
- Run a recall and safety report across every FHS manufacturer
- Watch product code FHS 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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