FDA product code HSP: Splint, Traction
HSP is the FDA product code for splint, traction. It is a Class I device, regulated under 21 CFR 888.5890 and reviewed by the Orthopedic panel. FDA has cleared 1 510(k) submission under HSP. The average 510(k) review took 66 days (median 66). FDA has posted 1 recall for HSP devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Splint, Traction |
| Device class | Class I |
| Regulation | 21 CFR 888.5890 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every HSP clearance
Top HSP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Chase Mfg. Co. | 1 | 1977-07-21 |
Most recent HSP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K770898 | Chase Mfg. Co. | FRACTURE CAST BRACE KIT, PLASTIC | 1977-07-21 | 66 |
Recalls for HSP devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2024-02-27.
| Year | Recalls |
|---|---|
| 2024 | 1 |
Frequently asked questions
What is FDA product code HSP?
HSP is the FDA product code for splint, traction. It is a Class I device, regulated under 21 CFR 888.5890 and reviewed by the Orthopedic panel.
What device class is HSP?
Class I, regulation 21 CFR 888.5890. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HSP?
Across 1 cleared submissions the average was 66 days from receipt to decision (median 66).
Which companies have the most HSP clearances?
Chase Mfg. Co. (1).
Have HSP devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2024-02-27.
Next steps
- Run an FDA pathway report with predicate devices for product code HSP
- Run a recall and safety report across every HSP manufacturer
- Watch product code HSP 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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