FDA product code HBL: Holder, Head, Neurosurgical (Skull Clamp)
HBL is the FDA product code for holder, head, neurosurgical (skull clamp). It is a Class II device, regulated under 21 CFR 882.4460 and reviewed by the Neurology panel. FDA has cleared 50 510(k) submissions under HBL, 3 in the last five years, from 22 different applicants. The average 510(k) review took 128 days (median 104); 160 days on average over the last three years. FDA has posted 14 recalls for HBL devices, 3 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Holder, Head, Neurosurgical (Skull Clamp) |
| Device class | Class II |
| Regulation | 21 CFR 882.4460 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for HBL
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 90 |
| 2019 | 2 | 116 |
| 2020 | 2 | 204 |
| 2021 | 1 | 119 |
| 2024 | 2 | 55 |
| 2025 | 1 | 265 |
Compare with all 510(k) review times · Search every HBL clearance
Top HBL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Integra LifeSciences Corporation | 7 | 2014-11-24 |
| Ohio Medical Instrument Co., Inc. | 7 | 2002-07-29 |
| Pro Med Instruments GmbH | 6 | 2024-07-26 |
| Codman & Shurtleff, Inc. | 5 | 1991-09-19 |
| Imris, Inc. | 3 | 2014-09-04 |
17 more applicants have HBL clearances. See the full list in Caduvo.
Most recent HBL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K250423 | Medical Bees GmbH | mb-FIX Cranial Stabilization Systems | 2025-11-06 | 265 |
| K241883 | Pro Med Instruments GmbH | DORO Sterile Disposable Skull Pins Stainless Steel, Adult (36 pcs) (3006-00); DORO Sterile Disposable Skull Pins Stainless Steel, Pediatric (36 pcs) (3006-10); DORO Sterile Disposable Skull Pin Titanium, Adult (36 pcs) (3006-20); DORO Sterile Disposable Skull Pin Titanium, Pediatric (36 pcs) (3006-30); DORO Sterile Disposable Skull Pin Stainless Steel, Adult (36 pcs) (3006-50) | 2024-07-26 | 28 |
| K240319 | Pro Med Instruments GmbH | DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101.040) | 2024-04-24 | 82 |
| K203505 | Pro Med Instruments GmbH | DORO QR3 Headrest System (Aluminum) | 2021-03-29 | 119 |
| K193438 | Pro Med Instruments GmbH | DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium) | 2020-06-02 | 174 |
Recalls for HBL devices
14 product recalls in 12 recall events; 3 initiated in the last five years and 2 still open. Most recent: 2025-12-08.
| Year | Recalls |
|---|---|
| 2017 | 2 |
| 2018 | 3 |
| 2019 | 1 |
| 2020 | 1 |
| 2022 | 1 |
| 2025 | 2 |
Frequently asked questions
What is FDA product code HBL?
HBL is the FDA product code for holder, head, neurosurgical (skull clamp). It is a Class II device, regulated under 21 CFR 882.4460 and reviewed by the Neurology panel.
What device class is HBL?
Class II, regulation 21 CFR 882.4460. Typical premarket route: 510(k).
How long does a 510(k) take for product code HBL?
Across 50 cleared submissions the average was 128 days from receipt to decision (median 104).
Which companies have the most HBL clearances?
Integra LifeSciences Corporation (7); Ohio Medical Instrument Co., Inc. (7); Pro Med Instruments GmbH (6); Codman & Shurtleff, Inc. (5); Imris, Inc. (3).
Have HBL devices been recalled?
Yes: 14 product recalls across 12 recall events; the most recent began 2025-12-08.
Next steps
- Run an FDA pathway report with predicate devices for product code HBL
- Run a recall and safety report across every HBL manufacturer
- Watch product code HBL 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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