510(k) · Cleared
ClearedCablecap
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sensormed · FST Light, Surgical, Fiberoptic
Cleared on Jan 12, 2012 as substantially equivalent to K101496 (Sensormed, 2010) after a 59-day review. Its family tree reaches back 4 generations to 2004.
- Decided
- Jan 12, 2012
- Review
- 59 days
- Class
- Class II
- Product code
- FST
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K042034 (2004). 5 ancestors in all, the oldest K904378 (1991). No later device cites it as a predicate yet.
- Root · 4 generations backK042034 Nuvasive Maxcess Light GuideNuvasive, Inc. · 2004
- 3 generations backK080367 Zimmer Mis LightZimmer Spine, Inc. · 2008
- 2 generations backK082992 Axxion Light GuideSpinal Elements, Inc. · 2009
- 1 generation backK101496 Cablecap Model: WLF, STZ, AcmSensormed · 2010
- This deviceK113330 CablecapSensormed · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K042034 | Nuvasive Maxcess Light Guide | Nuvasive, Inc. | 2004 | — |
| −3 | K080367 | Zimmer Mis Light | Zimmer Spine, Inc. | 2008 | — |
| −2 | K082992 | Axxion Light Guide | Spinal Elements, Inc. | 2009 | — |
| −1 | K101496 | Cablecap Model: WLF, STZ, Acm | Sensormed | 2010 | — |
| 0 (this device) | K113330 | Cablecap | Sensormed | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 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.
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? (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 |
|---|---|---|---|
| * | K101496 | Cablecap Model: WLF, STZ, AcmSummary page 1…ansmitted through the cable in order to prevent patient burns and igniting flammable items in the surgical suite. Predicate Device SensorMed Reusable CableCap device (K101496) Technology Comparison Both devices are constructed from biocompatible plastics. Both are accessories to high in… | 2010 |
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?
- The line of descent spans 8 years and passes through 4 companies; a new generation was cleared every 1.6 years on median.
- None of the 5 ancestors has a recall.
How does its category compare?
All FST devicesFST Light, Surgical, Fiberoptic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 device absorbs and diffuses the light transmitted through the cable in order to
prevent patient burns and igniting flammable items in the surgical suite.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113330 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113330: Cablecap.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113330
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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