510(k) · Cleared
ClearedOphthalmic Light Pipe Pick
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Trek Medical Products, Inc. · FST Light, Surgical, Fiberoptic
Cleared on Mar 7, 1988 after an 81-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.
- Decided
- Mar 7, 1988
- Review
- 81 days
- Class
- Class II
- Product code
- FST
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK875195 Ophthalmic Light Pipe PickTrek Medical Products, Inc. · 1988
- Descendant · cites it directly · 0 of its ownK964553 Mbi CO-Axial Illuminated Retinal PickM.B. Industries, Inc. · 1997
- Descendant · cites it directly · 0 of its ownK964405 Mbi Illuminated Retinal PickM.B. Industries, Inc. · 1997
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) | K875195 | Ophthalmic Light Pipe Pick | Trek Medical Products, Inc. | 1988 | — |
| +1 | K964553 | Mbi CO-Axial Illuminated Retinal Pick | M.B. Industries, Inc. | 1997 | — |
| +1 | K964405 | Mbi Illuminated Retinal Pick | M.B. Industries, Inc. | 1997 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FST? 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 FST device
- #1 K200874 TruView Light Cable, TruView Lateral Retractor…score -0.4 · 1 generation · no Class I recall
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
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, K964553 (M.B. Industries, Inc., 1997) has gone furthest, with 0 descendants of its own.
How does its category compare?
All FST devicesFST Light, Surgical, Fiberoptic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FST
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · FST
59in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FST
1in 2014
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FST
27in 2025
MAUDE reports naming product code FST, 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 | 1 | — | 0 | 3 |
| 2008 | 2 | — | 0 | 2 |
| 2009 | 3 | 100 | 0 | 4 |
| 2010 | 5 | 90 | 0 | 3 |
| 2011 | 0 | — | 10 | 7 |
| 2012 | 3 | 59 | 0 | 14 |
| 2013 | 0 | — | 0 | 9 |
| 2014 | 1 | — | 1 | 13 |
| 2015 | 0 | — | 0 | 14 |
| 2016 | 0 | — | 0 | 15 |
| 2017 | 0 | — | 0 | 20 |
| 2018 | 0 | — | 0 | 12 |
| 2019 | 0 | — | 0 | 29 |
| 2020 | 1 | — | 0 | 33 |
| 2021 | 0 | — | 0 | 20 |
| 2022 | 0 | — | 0 | 11 |
| 2023 | 0 | — | 0 | 11 |
| 2024 | 0 | — | 0 | 40 |
| 2025 | 0 | — | 0 | 27 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K875195 · printed Nov 4, 2026
Cite this page
510(k) Report. “K875195: Ophthalmic Light Pipe Pick.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K875195
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026