FDA product code HBA: Neurosurgical Paddie
HBA is the FDA product code for neurosurgical paddie. It is a Class II device, regulated under 21 CFR 882.4700 and reviewed by the Neurology panel. FDA has cleared 24 510(k) submissions under HBA, from 18 different applicants. The average 510(k) review took 168 days (median 102). FDA has posted 78 recalls for HBA devices, 26 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Neurosurgical Paddie |
| Device class | Class II |
| Regulation | 21 CFR 882.4700 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for HBA
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 1 | 353 |
Compare with all 510(k) review times · Search every HBA clearance
Top HBA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| American Silk Sutures, Inc. | 4 | 1991-03-27 |
| Ultracell Medical Technologies, Inc. | 3 | 1997-12-09 |
| American Surgical Company, LLC | 2 | 2013-06-20 |
| Integra LifeSciences Corporation | 1 | 2020-11-20 |
| Medline Industries, Inc. | 1 | 2014-09-26 |
13 more applicants have HBA clearances. See the full list in Caduvo.
Most recent HBA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K193346 | Integra LifeSciences Corporation | Codman Surgical Patties & Strips | 2020-11-20 | 353 |
| K140369 | Medline Industries, Inc. | MEDLINE NEURO SPONGE | 2014-09-26 | 224 |
| K112598 | American Surgical Company, LLC | AMERICAN SURGICAL COMPANY/ NEUROSURGICAL SPONGES (BRAND) | 2013-06-20 | 652 |
| K121822 | American Surgical Company, LLC | DELICOT | 2012-09-10 | 81 |
| K073576 | Harod Enterprises, Inc. | NEUROSURGICAL SPONGES AND PADDLES AND NEURO PATTIES AND NEUROSPONGES | 2008-02-22 | 65 |
Recalls for HBA devices
78 product recalls in 6 recall events; 26 initiated in the last five years and 26 still open. Most recent: 2026-03-19.
| Year | Recalls |
|---|---|
| 2022 | 1 |
| 2024 | 23 |
| 2026 | 2 |
Frequently asked questions
What is FDA product code HBA?
HBA is the FDA product code for neurosurgical paddie. It is a Class II device, regulated under 21 CFR 882.4700 and reviewed by the Neurology panel.
What device class is HBA?
Class II, regulation 21 CFR 882.4700. Typical premarket route: 510(k).
How long does a 510(k) take for product code HBA?
Across 24 cleared submissions the average was 168 days from receipt to decision (median 102).
Which companies have the most HBA clearances?
American Silk Sutures, Inc. (4); Ultracell Medical Technologies, Inc. (3); American Surgical Company, LLC (2); Integra LifeSciences Corporation (1); Medline Industries, Inc. (1).
Have HBA devices been recalled?
Yes: 78 product recalls across 6 recall events; the most recent began 2026-03-19.
Next steps
- Run an FDA pathway report with predicate devices for product code HBA
- Run a recall and safety report across every HBA manufacturer
- Watch product code HBA 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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