510(k) · Cleared
ClearedTruView Light Cable, TruView Lateral Retractor Light Cable, Bifurcated Light Cable With Universal End
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innovasis, Inc. · FST Light, Surgical, Fiberoptic
Cleared on Jun 30, 2020 as substantially equivalent to K042034 (Nuvasive, Inc., 2004) and 1 other predicate after a 90-day review. Its family tree reaches back 1 generation to 1990.
- Decided
- Jun 30, 2020
- Review
- 90 days
- Class
- Class II
- Product code
- FST
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K901035 (1990). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK901035 Fiber Optic Light Guide or Fiber Optic CableCuda Products Co. · 1990
- This deviceK200874 TruView Light Cable, TruView Lateral Retractor Light Cable…Innovasis, Inc. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K901035 | Fiber Optic Light Guide or Fiber Optic Cable | Cuda Products Co. | 1990 | — |
| 0 (this device) | K200874 | TruView Light Cable, TruView Lateral Retractor Light Cable, Bifurcated Light… | Innovasis, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 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 FST? 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? (2)
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 |
|---|---|---|---|
| * | K042034 | Nuvasive Maxcess Light GuideSummary page 4….4580 Class 2 Product Code: FST Review Panel: General & Plastic Surgery Primary Predicate: K042034 NuVasive, Inc. MaXcess Light Guide This predicate has not been subject to a design-related recall… | 2004 |
| * | K901035 | Fiber Optic Light Guide or Fiber Optic CableSummary page 4…Inc. MaXcess Light Guide This predicate has not been subject to a design-related recall. Additional Predicate: K901035 Cuda Products Co./Sunoptic Technologies Fiberoptic Light Cable Device De… | 1990 |
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?
- None of the 2 ancestors has a recall.
- 4 other devices also cite its predicate K042034.
How does its category compare?
All FST devicesFST Light, Surgical, Fiberoptic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
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 | — |
What is it indicated for?
The TruView Light Cable is intended to provide surgical site illumination from a fiber optic light source.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200874 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200874: TruView Light Cable, TruView Lateral Retractor Light Cable, Bifurcated Light Cable With Universal End.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200874
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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