510(k) · Cleared
ClearedEndoscopic Fiberoptic Cable
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Isolux America · HBI Illuminator, Fiberoptic, Surgical Field
Cleared on Jun 23, 1999 after a 75-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it.
- Decided
- Jun 23, 1999
- Review
- 75 days
- Class
- Class II
- Product code
- HBI
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK991208 Endoscopic Fiberoptic CableIsolux America · 1999
- Descendant · cites it directly · 1 of its ownK111342 Light Guide CableSchott North America · 2011
- Descendant · 2 generations on · 0 of its ownK223183 Light-Guide CablesOlympus Winter & Ibe GmbH · 2023
- Descendant · cites it directly · 0 of its ownK070287 PS Series with Fiber Light Guide and Headlight, Models PS200, PS250…Photonic Optische Gerate GmbH & Cokg · 2007
Most influential descendants
Showing 3 of 3 · See all- K111342Light Guide CableSchott North America · 2011 · cites it directly1descendant
- K223183Light-Guide CablesOlympus Winter & Ibe GmbH · 2023 · 2 generations on0descendants
- K070287PS Series with Fiber Light Guide and Headlight, Models PS200, PS250, PS500Photonic Optische Gerate GmbH & Cokg · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K991208 | Endoscopic Fiberoptic Cable | Isolux America | 1999 | — |
| +1 | K111342 | Light Guide Cable | Schott North America | 2011 | — |
| +2 | K223183 | Light-Guide Cables | Olympus Winter & Ibe GmbH | 2023 | — |
| +1 | K070287 | PS Series with Fiber Light Guide and Headlight, Models PS200, PS250, PS500 | Photonic Optische Gerate GmbH & Cokg | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HBI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HBI device
- #1 K223183 Light-Guide Cablesscore 5.0 · 2 generations · no Class I recall
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K111342 (Schott North America, 2011) has gone furthest, with 1 descendant of its own.
How does its category compare?
All HBI devicesHBI Illuminator, Fiberoptic, Surgical Field: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HBI
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · HBI
Too few HBI 510(k)s in any year since 2007 to give a median.
Recalls per year · HBI
No recall names HBI since 2007.
Adverse event reports per year · HBI
1in 2025
MAUDE reports naming product code HBI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 2 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 3 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 1 | — | 0 | 1 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 3 |
| 2019 | 0 | — | 0 | 5 |
| 2020 | 0 | — | 0 | 6 |
| 2021 | 0 | — | 0 | 4 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 1 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The ISOLUX America’s fiber optic cable is indicated for use in transmitting light for illumination purposes from an illuminator to various instruments such as headlights, microscopes and endoscopes, providing illumination in body cavities during examinations or surgical procedures.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K991208 · printed Nov 6, 2026
Cite this page
510(k) Report. “K991208: Endoscopic Fiberoptic Cable.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991208
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026