510(k) · Cleared
ClearedOphtacath Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
France Chirurgae Instrumentation · OKS Lacrimal Stents And Intubation Sets
Cleared on Jul 29, 2013 as substantially equivalent to K113867 (Quest Medical, Inc., 2012) and 2 other predicates after a 229-day review. Its family tree reaches back 5 generations to 1985.
- Decided
- Jul 29, 2013
- Review
- 229 days
- Class
- Class U
- Product code
- OKS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K854261 (1985). 13 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK854261 Advanced Cardiovascular Systems Hemostatic ValvesAdvanced Cardiovascular Systems, Inc. · 1985 · Recalled
- 4 generations backK991102 Copilot Bleedback Control Valve, Model 1003331Guidant Corp. · 1999 · Recalled
- 3 generations backK040498 MyshellSedat S.A. · 2004
- 2 generations backK042449 Dolphin Inflation DeviceSedat S.A. · 2005 · Recalled
- 1 generation backK082755 Sedat FlamingoSedat · 2008 · Recalled
- This deviceK123831 Ophtacath KitFrance Chirurgae Instrumentation · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K854261 | Advanced Cardiovascular Systems Hemostatic Valves | Advanced Cardiovascular Systems, Inc. | 1985 | 2 |
| −4 | K991102 | Copilot Bleedback Control Valve, Model 1003331 | Guidant Corp. | 1999 | 1 |
| −3 | K040498 | Myshell | Sedat S.A. | 2004 | — |
| −2 | K042449 | Dolphin Inflation Device | Sedat S.A. | 2005 | 4 |
| −1 | K082755 | Sedat Flamingo | Sedat | 2008 | 1 |
| 0 (this device) | K123831 | Ophtacath Kit | France Chirurgae Instrumentation | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 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 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? (3)
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 |
|---|---|---|---|
| * | K113867 | Lacricath Lacrimal Duct Catheter | 2012 |
| * | K082755 | Sedat FlamingoSummary page 1…® was originally cleared for marketing for use as an inflation device with cardiovascular balloon catheters as the Sedat Flamingo, 5 10(k) Premarket Notification Number: K082755, FDA Product Code MAy, Class 11.… | 2008 |
| * | K972964 | Atrion Medical Balloon Catheter Inflation DeviceSummary page 2…mum safe use of the device. Similarly, the Atrion QL® Balloon Catheter Inflation Device was originally cleared for marketing under 510(k) Premarket Notification Number: K972964, FDA Product Code KOE, Subsequent Product Code HNW. The ophthalmic indication for use with lacrimal balloon catheters was added t… | 1997 |
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 28 years and passes through 5 companies; a new generation was cleared every 4.6 years on median.
- 5 of the 13 ancestors have a recall of any class.
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. 2013, 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 OphtaCath®D Unilateral Kits (2-mm and 3-mm) are intended for use during dilation of the obstructed nasolacrimal duct to treat epiphora. For patients older than 12 months but under 30 months, the recommended catheter is the 2 mm balloon diameter. For patients 30 months and older, the recommended catheter is the 3 mm balloon diameter.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123831 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123831: Ophtacath Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123831
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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