510(k) · Cleared
ClearedCablecap Model: WLF, STZ, Acm
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sensormed · FST Light, Surgical, Fiberoptic
Cleared on Sep 14, 2010 as substantially equivalent to K082992 (Spinal Elements, Inc., 2009) after a 105-day review. Its family tree reaches back 3 generations to 2004. 1 later device descends from it.
- Decided
- Sep 14, 2010
- Review
- 105 days
- Class
- Class II
- Product code
- FST
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K042034 (2004). 4 ancestors in all, the oldest K904378 (1991). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK042034 Nuvasive Maxcess Light GuideNuvasive, Inc. · 2004
- 2 generations backK080367 Zimmer Mis LightZimmer Spine, Inc. · 2008
- 1 generation backK082992 Axxion Light GuideSpinal Elements, Inc. · 2009
- This deviceK101496 Cablecap Model: WLF, STZ, AcmSensormed · 2010
- Descendant · cites it directly · 0 of its ownK113330 CablecapSensormed · 2012
Most influential descendants
Showing 1 of 1 · See all- K113330CablecapSensormed · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K042034 | Nuvasive Maxcess Light Guide | Nuvasive, Inc. | 2004 | — |
| −2 | K080367 | Zimmer Mis Light | Zimmer Spine, Inc. | 2008 | — |
| −1 | K082992 | Axxion Light Guide | Spinal Elements, Inc. | 2009 | — |
| 0 (this device) | K101496 | Cablecap Model: WLF, STZ, Acm | Sensormed | 2010 | — |
| +1 | K113330 | Cablecap | Sensormed | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 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 |
|---|---|---|---|
| * | K082992 | Axxion Light GuideSummary page 1…le items in the surgical suite. The device is not intended to be used to illuminate the surgical field. Predicate Device Axxion Light Guide from Spinal Elements, Inc. (1K082992) Technology Comparison Both devices are constructed from biocompatible steel, and plastics. Both are accessories… | 2009 |
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 |
|---|---|---|---|
| K113330 | Cablecap | 2012 | 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?
- The line of descent spans 6 years and passes through 4 companies; a new generation was cleared every 1.6 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K113330 (Sensormed, 2012) 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. 2010, 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 CableCap device attaches to the distal end of high intensity light cables. The device absorbs and diffuses the light transmitted through the cable in order to prevent p~atient burns and igniting-flammable items in the surgidal suite. It is necessary to check each light cable to determine which CableCap model (STZ, ACM, WLF) to use. See product instructions for cleaning and sterilization protocols.
The device is not intended to be used to illuminate the surgical field.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101496 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101496: Cablecap Model: WLF, STZ, Acm.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101496
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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