FDA product code HBM: Headrest, Neurosurgical
HBM is the FDA product code for headrest, neurosurgical. It is a Class I device, regulated under 21 CFR 882.4440 and reviewed by the Neurology panel. FDA has cleared 3 510(k) submissions under HBM, from 2 different applicants. The average 510(k) review took 61 days (median 78). FDA has posted 2 recalls for HBM devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Headrest, Neurosurgical |
| Device class | Class I |
| Regulation | 21 CFR 882.4440 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HBM clearance
Top HBM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Codman & Shurtleff, Inc. | 2 | 1991-07-17 |
| Kelleher Corp. | 1 | 1982-08-20 |
Most recent HBM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K911917 | Codman & Shurtleff, Inc. | CODMAN PEDIATRIC HORSESHOE HEADREST | 1991-07-17 | 78 |
| K911918 | Codman & Shurtleff, Inc. | SWIVEL HORSESHOE HEADREST | 1991-07-17 | 78 |
| K822169 | Kelleher Corp. | SURGICAL HEAD SUPPORT | 1982-08-20 | 28 |
Recalls for HBM devices
2 product recalls in 1 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2023-12-12.
| Year | Recalls |
|---|---|
| 2023 | 2 |
Frequently asked questions
What is FDA product code HBM?
HBM is the FDA product code for headrest, neurosurgical. It is a Class I device, regulated under 21 CFR 882.4440 and reviewed by the Neurology panel.
What device class is HBM?
Class I, regulation 21 CFR 882.4440. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HBM?
Across 3 cleared submissions the average was 61 days from receipt to decision (median 78).
Which companies have the most HBM clearances?
Codman & Shurtleff, Inc. (2); Kelleher Corp. (1).
Have HBM devices been recalled?
Yes: 2 product recalls across 1 recall events; the most recent began 2023-12-12.
Next steps
- Run an FDA pathway report with predicate devices for product code HBM
- Run a recall and safety report across every HBM manufacturer
- Watch product code HBM 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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