510(k) Report

510(k) · Cleared

Cleared

Stoploss Jones Tube

K140290510(k) TraditionalCleared Dec 2, 2014300-day reviewClass U

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

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.

Other ancestors, by year cleared 2006: 1 other ancestor1999: 1 other ancestor1996: 1 other ancestorK883233 · EV Monocanalicular Stent (TM) · Eagle Vision, Inc. · 1988K030353 · Monocanalicular Stents, Lacrimal Intubation Sets · Eagle Vision, Inc. · 2003K113316 · DCS Lacrimal Stent · Dcs Surgical, Inc. · 20121985199019952000200520102015
Other ancestors, by generation 2 generations back: 1 other ancestor3 generations back: 2 other ancestors K113316 · DCS Lacrimal Stent · Dcs Surgical, Inc. · 2012K030353 · Monocanalicular Stents, Lacrimal Intubation Sets · Eagle Vision, Inc. · 2003K883233 · EV Monocanalicular Stent (TM) · Eagle Vision, Inc. · 19880
  1. Root · 3 generations backK883233 EV Monocanalicular Stent (TM)Eagle Vision, Inc. · 1988
  2. 2 generations backK030353 Monocanalicular Stents, Lacrimal Intubation SetsEagle Vision, Inc. · 2003
  3. 1 generation backK113316 DCS Lacrimal StentDcs Surgical, Inc. · 2012
  4. This deviceK140290 Stoploss Jones TubeLjt Surgical, Ltd. · 2014
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K883233EV Monocanalicular Stent (TM)Eagle Vision, Inc.1988—
−2K030353Monocanalicular Stents, Lacrimal Intubation SetsEagle Vision, Inc.2003—
−1K113316DCS Lacrimal StentDcs Surgical, Inc.2012—
0 (this device)K140290Stoploss Jones TubeLjt Surgical, Ltd.2014—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199610
199910
200610
FIG. 1 — Lineage of K140290, 1988–2014Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K201892 Ritleng®+ and Ritleng®+ PVPscore 1.0 · 1 generation · no Class I recall
  2. #2 Held for the reportin the report
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K113316DCS Lacrimal Stent
Summary 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…
Dcs Surgical, Inc.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 devices

OKS 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

2012: 72013: 22014: 12015: 12016: 22017: 12020: 12021: 1
2007high 7 (2012) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OKS

277in 2012

2012: 277 days median
2007high 277 (2012)2026

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

2011: 22012: 32013: 32014: 82015: 142016: 212017: 182018: 62019: 82020: 22021: 62022: 3
2007high 21 (2016) · low 0 (2007)2025

MAUDE reports naming product code OKS, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—02
2012727703
20132—03
20141—08
20151—014
20162—021
20171—018
20180—06
20190—08
20201—02
20211—06
20220—03
20230—00
20240—00
20250—00
20260—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.

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