FDA product code FSD: Binder, Abdominal
FSD is the FDA product code for binder, abdominal. It is a Class I device, regulated under 21 CFR 880.5160 and reviewed by the General Hospital panel. FDA has cleared 5 510(k) submissions under FSD, from 5 different applicants. The average 510(k) review took 58 days (median 30).
Classification
| Field | Value |
|---|---|
| Device name | Binder, Abdominal |
| Device class | Class I |
| Regulation | 21 CFR 880.5160 |
| 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 FSD clearance
Top FSD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Kuhn Industries | 1 | 1989-07-20 |
| Fidelty Hearing Instruments, Inc. | 1 | 1983-01-18 |
| Oticon Corp. | 1 | 1981-03-04 |
| R.G. Moore | 1 | 1977-02-09 |
| Tecnol New Jersey Wound Care, Inc. | 1 | 1976-11-03 |
Most recent FSD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K892379 | Kuhn Industries | THE POUCH GROIN & ABDOMINAL STRESS AID | 1989-07-20 | 105 |
| K822817 | Fidelty Hearing Instruments, Inc. | DOCE ALL-IN-THE-EAR AID | 1983-01-18 | 120 |
| K810379 | Oticon Corp. | EARETTE HEARING AID SEARS #8054 | 1981-03-04 | 19 |
| K770162 | R.G. Moore | MATERNITY SUPPORTER | 1977-02-09 | 16 |
| K760772 | Tecnol New Jersey Wound Care, Inc. | DISPOSABLE ABDOMINAL BINDER | 1976-11-03 | 30 |
Recalls for FSD devices
openFDA lists no recalls for product code FSD.
Frequently asked questions
What is FDA product code FSD?
FSD is the FDA product code for binder, abdominal. It is a Class I device, regulated under 21 CFR 880.5160 and reviewed by the General Hospital panel.
What device class is FSD?
Class I, regulation 21 CFR 880.5160. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FSD?
Across 5 cleared submissions the average was 58 days from receipt to decision (median 30).
Which companies have the most FSD clearances?
Kuhn Industries (1); Fidelty Hearing Instruments, Inc. (1); Oticon Corp. (1); R.G. Moore (1); Tecnol New Jersey Wound Care, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FSD
- Run a recall and safety report across every FSD manufacturer
- Watch product code FSD 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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