510(k) · Cleared
ClearedLight Guide Cable
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Schott North America · HBI Illuminator, Fiberoptic, Surgical Field
Cleared on Nov 25, 2011 as substantially equivalent to K991208 (Isolux America, 1999) after a 196-day review. Its family tree reaches back 1 generation to 1999. 1 later device descends from it.
- Decided
- Nov 25, 2011
- Review
- 196 days
- Class
- Class II
- Product code
- HBI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K991208 (1999). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K223183Light-Guide CablesOlympus Winter & Ibe GmbH · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K991208 | Endoscopic Fiberoptic Cable | Isolux America | 1999 | — |
| 0 (this device) | K111342 | Light Guide Cable | Schott North America | 2011 | — |
| +1 | K223183 | Light-Guide Cables | Olympus Winter & Ibe GmbH | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and 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? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K991208 | Endoscopic Fiberoptic CableSummary page 1…Fiberoptic Cable Classification Name: Surgical Lamp 3. PREDICATE DEVICE Endoscopic Fiber Optic Cable marketed by Isolux America, K991208 4. DEVICE DESCRIPTION The Light guide cable consists of glass fibers which are glued or fused into ferrules on both ends.… | 1999 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K223183 | Light-Guide Cables | 2023 | 0 |
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?
How does its category compare?
All HBI devicesHBI Illuminator, Fiberoptic, Surgical Field: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
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 Schott Light Guide 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 as stated in the FDA summary.
https://510kreport.com/device/K111342 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111342: Light Guide Cable.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111342
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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