510(k) · Cleared
ClearedStoploss Jones Tube
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ljt Surgical, Ltd. · OKS Lacrimal Stents And Intubation Sets
Cleared on Dec 2, 2014 as substantially equivalent to K113316 (Dcs Surgical, Inc., 2012) after a 300-day review. Its family tree reaches back 3 generations to 1988.
- Decided
- Dec 2, 2014
- Review
- 300 days
- Class
- Class U
- Product code
- OKS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K883233 (1988). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK883233 EV Monocanalicular Stent (TM)Eagle Vision, Inc. · 1988
- 2 generations backK030353 Monocanalicular Stents, Lacrimal Intubation SetsEagle Vision, Inc. · 2003
- 1 generation backK113316 DCS Lacrimal StentDcs Surgical, Inc. · 2012
- This deviceK140290 Stoploss Jones TubeLjt Surgical, Ltd. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K883233 | EV Monocanalicular Stent (TM) | Eagle Vision, Inc. | 1988 | — |
| −2 | K030353 | Monocanalicular Stents, Lacrimal Intubation Sets | Eagle Vision, Inc. | 2003 | — |
| −1 | K113316 | DCS Lacrimal Stent | Dcs Surgical, Inc. | 2012 | — |
| 0 (this device) | K140290 | Stoploss Jones Tube | Ljt Surgical, Ltd. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2006 | 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 OKS? 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 OKS device
- #1 K201892 Ritleng®+ and Ritleng®+ PVPscore 1.0 · 1 generation · no Class I recall
- #2 Held for the reportin 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 |
|---|---|---|---|
| * | K113316 | DCS Lacrimal StentSummary page 4…er Weiss Scientific Glassblowing Co., Inc.: Jones Tube (Pre-Amendment device) DCS Surgical, Inc., DCS Lacrimal Stent (K113316) Indications for Use The StopLoss Jones tube system is intended for use during Statement: repair of the lacrim… | 2012 |
| * | — | Gunther Weiss Scientific Glassblowing Co., Inc.: Jones Tube Named without a submission number |
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 26 years and passes through 3 companies; a new generation was cleared every 9.5 years on median.
- None of the 6 ancestors has a recall.
How does its category compare?
All OKS devicesOKS Lacrimal Stents And Intubation Sets: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · OKS
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · OKS
277in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OKS
No recall names OKS since 2007.
Adverse event reports per year · OKS
3in 2022
MAUDE reports naming product code OKS, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 2 |
| 2012 | 7 | 277 | 0 | 3 |
| 2013 | 2 | — | 0 | 3 |
| 2014 | 1 | — | 0 | 8 |
| 2015 | 1 | — | 0 | 14 |
| 2016 | 2 | — | 0 | 21 |
| 2017 | 1 | — | 0 | 18 |
| 2018 | 0 | — | 0 | 6 |
| 2019 | 0 | — | 0 | 8 |
| 2020 | 1 | — | 0 | 2 |
| 2021 | 1 | — | 0 | 6 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The StopLoss Jones tube system is intended for use during repair of the lacrimal system for intubation and bypass to canalicular pathologies.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140290 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140290: Stoploss Jones Tube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140290
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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