FDA product code HBI: Illuminator, Fiberoptic, Surgical Field
HBI is the FDA product code for illuminator, fiberoptic, surgical field. It is a Class II device, regulated under 21 CFR 878.4580 and reviewed by the General and Plastic Surgery panel. FDA has cleared 28 510(k) submissions under HBI, 1 in the last five years, from 18 different applicants. The average 510(k) review took 74 days (median 70).
Classification
| Field | Value |
|---|---|
| Device name | Illuminator, Fiberoptic, Surgical Field |
| Device class | Class II |
| Regulation | 21 CFR 878.4580 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for HBI
| Year | Clearances | Avg. review days |
|---|---|---|
| 2023 | 1 | 93 |
Compare with all 510(k) review times · Search every HBI clearance
Top HBI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Advanced Surgical Products, Inc. | 4 | 1989-02-17 |
| Storz Instrument Co. | 3 | 1991-04-19 |
| Isolux, LLC | 2 | 2016-11-21 |
| Progressive Dynamics, Inc. | 2 | 1993-10-28 |
| Nextec Corp. | 2 | 1992-09-21 |
13 more applicants have HBI clearances. See the full list in Caduvo.
Most recent HBI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K223183 | Olympus Winter & Ibe GmbH | Light-Guide Cables | 2023-01-13 | 93 |
| K163185 | Isolux, LLC | OptiLux LED Illuminator | 2016-11-21 | 7 |
| K141781 | Katalyst Surgical, LLC | KOGENT SPETZLER LIGHTED SUCTION TUBES | 2015-04-09 | 281 |
| K111342 | Schott North America | LIGHT GUIDE CABLE | 2011-11-25 | 196 |
| K052979 | Isolux, LLC | 1125 XSB XENON FIBER-OPTIC LIGHT SOURCE | 2005-10-31 | 7 |
Recalls for HBI devices
openFDA lists no recalls for product code HBI.
Frequently asked questions
What is FDA product code HBI?
HBI is the FDA product code for illuminator, fiberoptic, surgical field. It is a Class II device, regulated under 21 CFR 878.4580 and reviewed by the General and Plastic Surgery panel.
What device class is HBI?
Class II, regulation 21 CFR 878.4580. Typical premarket route: 510(k).
How long does a 510(k) take for product code HBI?
Across 28 cleared submissions the average was 74 days from receipt to decision (median 70).
Which companies have the most HBI clearances?
Advanced Surgical Products, Inc. (4); Storz Instrument Co. (3); Isolux, LLC (2); Progressive Dynamics, Inc. (2); Nextec Corp. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code HBI
- Run a recall and safety report across every HBI manufacturer
- Watch product code HBI 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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