510(k) · Cleared
ClearedTru-Cable
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Truphatek International, Ltd. · FFS Image, Illumination, Fiberoptic, For Endoscope
Cleared on Jan 12, 2007 as substantially equivalent to K001698 (Cogent Light Technologies, Inc., 2000) and 1 other predicate after a 71-day review. Its family tree reaches back 2 generations to 1998.
- Decided
- Jan 12, 2007
- Review
- 71 days
- Class
- Class II
- Product code
- FFS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K972225 (1998). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K972225 | Ufr Fiberoptic Cable | Universal Fiberoptic Repair, Inc. | 1998 | — |
| −1 | K023633 | Sovis Optique's Endoscopic Cable | Sovis Optique | 2002 | — |
| 0 (this device) | K063309 | Tru-Cable | Truphatek International, Ltd. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 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 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? (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 |
|---|---|---|---|
| * | K001698 | Micro Link Endoscopic Fiber Cable, Model B1-90159Summary page 1…Endoscope and / or accessories Device: Tru-CableTM Predicate Devices: Cogent - Micro Link - K001698 Sovis Optique - K023633 Device Description: The Truphatek Tru-CableTM endoscopic fiber op… | 2000 |
| * | K023633 | Sovis Optique's Endoscopic CableSummary page 1…e: Tru-CableTM Predicate Devices: Cogent - Micro Link - K001698 Sovis Optique - K023633 Device Description: The Truphatek Tru-CableTM endoscopic fiber optic cables are: * Lengths of 10 feet (3.5m) * Diameters… | 2002 |
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 9 years and passes through 3 companies; a new generation was cleared every 4.8 years on median.
- None of the 3 ancestors has a recall.
- 2 other devices also cite its predicate K001698.
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. 2007, this device’s year, is highlighted.
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?
The Tru-CableTM endoscopic fiber optic cable is designed to transmit light for
illumination purposes from a remote source to an endoscope or similar surgical
instrument. It can be adapted to be compatible with a variety of illuminators.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063309 · printed Nov 5, 2026
Cite this page
510(k) Report. “K063309: Tru-Cable.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K063309
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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