510(k) · Cleared
ClearedXenon Fiberoptic Light Source, Model 1300 XSBP
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Isolux America · HET Laparoscope, Gynecologic (And Accessories)
Cleared on Oct 18, 2002 after an 88-day review. The FDA summary names its predicate without a number. 2 later devices descend from it.
- Decided
- Oct 18, 2002
- Review
- 88 days
- Class
- Class II
- Product code
- HET
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK022384 Xenon Fiberoptic Light Source, Model 1300 XSBPIsolux America · 2002
- Descendant · cites it directly · 0 of its ownK061622 PS SeriesPhotonic Optische Gerate Gesmbh & Cokg · 2007
- 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 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K022384 | Xenon Fiberoptic Light Source, Model 1300 XSBP | Isolux America | 2002 | — |
| +1 | K061622 | PS Series | Photonic Optische Gerate Gesmbh & Cokg | 2007 | — |
| +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 | 2 | 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 HET? 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 HET device
- #1 K250939 SIRIUS Endoscope System (PR-SI-1230)score 12.9 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | — | Karl Storz Cold Light Fountain Xenon 300 Named without a submission number | |
| * | — | Maxenon Named without a submission number | |
| * | — | Brite Lite III Named without a submission number |
What descends from it? (2)
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, K061622 (Photonic Optische Gerate Gesmbh & Cokg, 2007) has gone furthest, with 0 descendants of its own.
How does its category compare?
All HET devicesHET Laparoscope, Gynecologic (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HET
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HET
269in 2021
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HET
4in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HET
4,513in 2025
MAUDE reports naming product code HET, 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 | 181 |
| 2008 | 3 | 176 | 4 | 359 |
| 2009 | 1 | — | 1 | 403 |
| 2010 | 1 | — | 0 | 214 |
| 2011 | 2 | — | 0 | 417 |
| 2012 | 2 | — | 0 | 1,118 |
| 2013 | 2 | — | 0 | 1,035 |
| 2014 | 0 | — | 0 | 175 |
| 2015 | 2 | — | 1 | 124 |
| 2016 | 0 | — | 0 | 205 |
| 2017 | 2 | — | 0 | 89 |
| 2018 | 1 | — | 0 | 53 |
| 2019 | 2 | — | 0 | 44 |
| 2020 | 2 | — | 0 | 49 |
| 2021 | 4 | 269 | 0 | 132 |
| 2022 | 1 | — | 1 | 216 |
| 2023 | 0 | — | 4 | 824 |
| 2024 | 0 | — | 0 | 3,496 |
| 2025 | 2 | — | 0 | 4,513 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The 1300 XSBP - 300 WATT XENON Illuminator is intended for use as a high intensity right to be used with fiberoptic cables. Applications include endoscopes, surgical headlights and other tools that contain fiberoptic bundles. Illumination from this device is intended to be used for observation of body cavities, hollow organs and other surgical sites. Specific areas of application include arthroscopy, laproscopy, gynecology, broncoscopy, urology and vascula endoscopy. The device is also intended for use as a light source for surgical headlights used in various open surgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022384 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022384: Xenon Fiberoptic Light Source, Model 1300 XSBP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022384
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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