FDA product code FYH: Splint, Extremity, Noninflatable, External, Sterile
FYH is the FDA product code for splint, extremity, noninflatable, external, sterile. It is a Class I device, regulated under 21 CFR 878.3910 and reviewed by the General Hospital panel. FDA has cleared 8 510(k) submissions under FYH, from 7 different applicants. The average 510(k) review took 71 days (median 49).
Classification
| Field | Value |
|---|---|
| Device name | Splint, Extremity, Noninflatable, External, Sterile |
| Device class | Class I |
| Regulation | 21 CFR 878.3910 |
| Review panel | HO — General Hospital |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every FYH clearance
Top FYH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Johnson & Johnson Professionals, Inc. | 2 | 1982-07-02 |
| Trace Medical Equipment, Inc. | 1 | 1993-05-19 |
| Johnson & Johnson Orthopaedics, Inc. | 1 | 1993-02-01 |
| Kut-Guard, Inc. | 1 | 1989-09-26 |
| The Huxley Instrument Corp. | 1 | 1985-07-02 |
2 more applicants have FYH clearances. See the full list in Caduvo.
Most recent FYH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K925145 | Trace Medical Equipment, Inc. | TRACE MODEL #'S 840, 841, 842, 845 | 1993-05-19 | 218 |
| K924984 | Johnson & Johnson Orthopaedics, Inc. | SPECIALIST(R) WALKER | 1993-02-01 | 123 |
| K895092 | Kut-Guard, Inc. | KUT-SHIELD | 1989-09-26 | 43 |
| K852558 | The Huxley Instrument Corp. | SPLINTS(ALL TYPE) | 1985-07-02 | 15 |
| K843400 | Compression Splint Products, Inc. | HYDRO-SPLINT A SPONGE-COMPRESS DRESS | 1984-10-24 | 55 |
Recalls for FYH devices
openFDA lists no recalls for product code FYH.
Frequently asked questions
What is FDA product code FYH?
FYH is the FDA product code for splint, extremity, noninflatable, external, sterile. It is a Class I device, regulated under 21 CFR 878.3910 and reviewed by the General Hospital panel.
What device class is FYH?
Class I, regulation 21 CFR 878.3910. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FYH?
Across 8 cleared submissions the average was 71 days from receipt to decision (median 49).
Which companies have the most FYH clearances?
Johnson & Johnson Professionals, Inc. (2); Trace Medical Equipment, Inc. (1); Johnson & Johnson Orthopaedics, Inc. (1); Kut-Guard, Inc. (1); The Huxley Instrument Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FYH
- Run a recall and safety report across every FYH manufacturer
- Watch product code FYH 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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