510(k) · Cleared
ClearedXenon 300MX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Perkinelmer Optoelectronics · FSS Light, Surgical, Floor Standing
Cleared on Apr 3, 1998 after an 87-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- Apr 3, 1998
- Review
- 87 days
- Class
- Class II
- Product code
- FSS
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK980044 Xenon 300MXPerkinelmer Optoelectronics · 1998
- Descendant · cites it directly · 0 of its ownK984124 Aesculap Xenon Light SourceAesculap, Inc. · 1999
Most influential descendants
Showing 1 of 1 · See all- K984124Aesculap Xenon Light SourceAesculap, Inc. · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K980044 | Xenon 300MX | Perkinelmer Optoelectronics | 1998 | — |
| +1 | K984124 | Aesculap Xenon Light Source | Aesculap, Inc. | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 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 FSS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 II Named without a submission number | |
| † | K971057 | Cogenlight Technologies XLS Illuminator System | 1997 |
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 |
|---|---|---|---|
| K984124 | Aesculap Xenon Light Source | 1999 | 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?
- Of its descendants, K984124 (Aesculap, Inc., 1999) has gone furthest, with 0 descendants of its own.
How does its category compare?
All FSS devicesFSS Light, Surgical, Floor Standing: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FSS
1in 2009
2026 to Oct 25, outlined.
Median 510(k) review, days · FSS
Too few FSS 510(k)s in any year since 2007 to give a median.
Recalls per year · FSS
No recall names FSS since 2007.
Adverse event reports per year · FSS
3in 2025
MAUDE reports naming product code FSS, 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 | 0 |
| 2009 | 1 | — | 0 | 3 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 3 |
| 2013 | 0 | — | 0 | 11 |
| 2014 | 0 | — | 0 | 14 |
| 2015 | 0 | — | 0 | 10 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 13 |
| 2020 | 0 | — | 0 | 9 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 15 |
| 2024 | 0 | — | 0 | 11 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Xenon 300mx Illuminator is intended for use as a high intensity light to be used with Fiberoptic cables. Applications include endoscopes, surgical headlamps, and other lighted tools that contained 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 vascular endoscopy. The device is also intended for use as a light source for surgical headlights used in various open surgical procedures. These indications are identical to those listed in the Cogent 510(k) number K971057.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K980044 · printed Nov 5, 2026
Cite this page
510(k) Report. “K980044: Xenon 300MX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K980044
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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