510(k) · Cleared
ClearedFiber Optic Endoillumination Probe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dutch Ophthalmic USA, Inc. · FFS Image, Illumination, Fiberoptic, For Endoscope
Cleared on May 20, 1998 as substantially equivalent to K870942 (Advanced Surgical Products, Inc., 1987) after a 90-day review. Its family tree reaches back 1 generation to 1987.
- Decided
- May 20, 1998
- Review
- 90 days
- Class
- Class II
- Product code
- FFS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K870942 (1987). No later device cites it as a predicate yet.
- Root · 1 generation backK870942 MVS Fiberoptic LightpipeAdvanced Surgical Products, Inc. · 1987
- This deviceK980636 Fiber Optic Endoillumination ProbeDutch Ophthalmic USA, Inc. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K870942 | MVS Fiberoptic Lightpipe | Advanced Surgical Products, Inc. | 1987 | — |
| 0 (this device) | K980636 | Fiber Optic Endoillumination Probe | Dutch Ophthalmic USA, Inc. | 1998 | — |
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 FFS? 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? (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 |
|---|---|---|---|
| * | K870942 | MVS Fiberoptic LightpipeSummary page 1…iber Probe Proprietary Name: Fiber Optic Endoillumination Probe Classification name: Light, Surgical, Fiberoptic PREDICATE DEVICE Infinitech, Inc. Fiber Optic Probe (K870942) DEVICE DESCRIPTION The Fiber Optic Endoillumination Probe provides intraocular illumination. The light is transmitted from the… | 1987 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K870942.
How does its category compare?
All FFS devicesFFS Image, Illumination, Fiberoptic, For Endoscope: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FFS
3in 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · FFS
74in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FFS
1in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FFS
5in 2024
MAUDE reports naming product code FFS, 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 | 3 | 74 | 1 | 12 |
| 2008 | 0 | — | 0 | 17 |
| 2009 | 0 | — | 0 | 14 |
| 2010 | 0 | — | 0 | 5 |
| 2011 | 0 | — | 0 | 7 |
| 2012 | 0 | — | 0 | 4 |
| 2013 | 0 | — | 0 | 10 |
| 2014 | 0 | — | 0 | 5 |
| 2015 | 0 | — | 0 | 4 |
| 2016 | 0 | — | 0 | 7 |
| 2017 | 0 | — | 0 | 19 |
| 2018 | 0 | — | 0 | 19 |
| 2019 | 0 | — | 0 | 17 |
| 2020 | 0 | — | 0 | 56 |
| 2021 | 0 | — | 0 | 57 |
| 2022 | 0 | — | 0 | 10 |
| 2023 | 0 | — | 0 | 6 |
| 2024 | 0 | — | 0 | 5 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Fiber Optic Endoillumination Probe is indicated for intraocular illumination in
vitreoretinal surgery.
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/K980636 · printed Nov 4, 2026
Cite this page
510(k) Report. “K980636: Fiber Optic Endoillumination Probe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980636
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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